KARL STORZ Endoscopy - America Jobs (9)

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13519

Pay Grade : US-C06

Salary Range : $15.14 - $22.89

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ Endoscopy America, Inc. Headquartered in El Segundo, California, KSEA is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices, and OR1® integration technologies.

KARL STORZ is currently seeking a Shipping / Receiving Mail Coordinator to join the Facilities Department.

Duties and Responsibilities :

• Receives from UPS, FedEx, USPS, and other freight companies.
• Posting of outbound deliveries VIA SAP.
• Prepares items for shipment using proper tools and packaging materials. Including, construction, crating, shrink wrapping, etc.
• Compares identifying information and counts weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices, orders, or other records.
• Examine incoming shipments, rejects / report damaged items, and record shortages.
• Maintain accurate inventory of shipping materials and supplies.
• Update required reports on a timely basis.
• Communicate with employees and assist with employees' needs.
• Coordinate inbound and outbound loads.
• Verify the accuracy of all shipping / receiving documentation.
• Assist in appointment scheduling as needed
• Pick up mail from USPS, process certified mail, and distribute company mail.
• Run monthly invoices through the Hasler machine
• Performs other related duties as assigned

Requirements :

• High school diploma (or equivalent)
• Domestic and foreign shipping knowledge.
• Basic Computer skills.
• Ability to meet deadlines.
• FedEx and UPS experience.
• Role requires driving KARL STORZ vehicle for tasks related to mail pick up.
• Candidates must have a valid driver's license in the state where the vehicle will be operated.

LI-KM1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13519

Pay Grade : US-C06

Salary Range : $15.14 - $22.89

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ Endoscopy America, Inc. Headquartered in El Segundo, California, KSEA is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices, and OR1® integration technologies.

KARL STORZ is currently seeking a Shipping / Receiving Mail Coordinator to join the Facilities Department.

Duties and Responsibilities :

• Receives from UPS, FedEx, USPS, and other freight companies.
• Posting of outbound deliveries VIA SAP.
• Prepares items for shipment using proper tools and packaging materials. Including, construction, crating, shrink wrapping, etc.
• Compares identifying information and counts weighs, or measures items of incoming and outgoing shipments to verify information against bills of lading, invoices, orders, or other records.
• Examine incoming shipments, rejects / report damaged items, and record shortages.
• Maintain accurate inventory of shipping materials and supplies.
• Update required reports on a timely basis.
• Communicate with employees and assist with employees' needs.
• Coordinate inbound and outbound loads.
• Verify the accuracy of all shipping / receiving documentation.
• Assist in appointment scheduling as needed
• Pick up mail from USPS, process certified mail, and distribute company mail.
• Run monthly invoices through the Hasler machine
• Performs other related duties as assigned

Requirements :

• High school diploma (or equivalent)
• Domestic and foreign shipping knowledge.
• Basic Computer skills.
• Ability to meet deadlines.
• FedEx and UPS experience.
• Role requires driving KARL STORZ vehicle for tasks related to mail pick up.
• Candidates must have a valid driver's license in the state where the vehicle will be operated.

LI-KM1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13498

Pay Grade : US-C16

Salary Range : $75,700 - 135,250

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ is a market leader in minimally invasive surgery and surgical visualization technologies. The Senior Data Analyst, OR1 will lead continuous improvement in the following areas of focus : OR1 Installation, Service, and Production and will support special projects.

OR1 is the high-tech commercial vertical of KARL STORZ, with hardware and software portfolios that drive Operating Room workflow efficiencies.

OR1 is a foundation of operating room infrastructures and leads in next-gen technologies.

The incumbent will be a core business partner and provide insight into the OR1 business and how to increase profitability by providing decision support, recommending process improvements, identifying new revenue opportunities, creating new metrics, and creating dashboards.

Additionally, he / she will be expected to provide ad-hoc analysis and relevant subject matter expertise.

We are seeking someone who lives for and LOVES data analytics and high tech for one of our faster growing divisions. Please click here to see a two minute video of our OR1 Division.

https : / / www.karlstorznetwork1.com / videos / clinician-and-patient-connectivity

Duties and responsibilities :

Production :

• Partner with key stakeholders to understand their business needs
• Lead cross-functional teams in the development of advanced analytics that identify operational improvements and efficiencies.
• Drives data mapping for manufacturing dashboards

Deployment Services :

• Bridge operations and finance to help maximize financial results
• Creating an OR1 Installation Dashboard by WBS / Project both for in-process and completed deals showing Actual and Plan Revenue and COS split by Material, Labor, and Travel by collaborating with OR1 Operations
• Use analysis to provide data-based recommendations, reports, and presentations including lessons learned from past deals and actual results
• Identifies metrics to manage field services teams in real-time using data analytics
• Identifies metrics / levers impacting the profitability of field services teams
• Tracks HR metrics that impact profitability and interrupt data to assist in the remediation

Project Success :

• Maximize return on investments by understanding the life of a project and what impacts a project's gross profit
• Track projects' success after the implementation is completed.
• Identifies analytics leading indicators that impact project GP

Service :

• Use data analytics to understand OR1 Service and develop new strategies to drive growth in the Service
• Understands data to be mined from the service ticketing system, and pulls data to create KPI dashboards on first-time fix rate, response time, field work order status, etc.
• Tracks HR metrics that impact profitability in service
• Model new ways for service delivery

Other Business Support :

• Build intuitive interfaces, infographics, and visualizations to tell stories with data.
• Create presentations with analysis and insights for both technical and non-technical audiences and present and interact with executives.
• Become a subject matter expert on the process and tools used within KARL STORZ
• Lead the analysis of new acquisition models, like XaaS
• Lead competitive market analysis preparation
• Lead development of sales metrics and business planning for the business unit.
• True business partner to Executive Management, looking for the story in the data, and assisting with executive readouts (such as QBRs).
• Systems super user : Understanding how data flows between SAP, Project Systems, HRIS, and Service Ticketing Systems.
• Completes other special projects as assigned.

Qualifications :

Education / Experience

• Bachelor's degree in a quantitative discipline (e.g., Statistics, Computer Science, Math, Engineering) or equivalent consulting experience); MBA preferred;
• 5+ years of experience with data exploration and visualization like Tableau, Looker, PowerBI, etc
• 3+ years of experience in data analytics, including building and deploying enterprise-wide data models with applications to real-world problems

Skills / Characteristics

• A well-qualified candidate should be highly technical with strong business acumen
• Self-starter with abundant intellectual curiosity who excels at framing problems analytically, is comfortable working through ambiguity, and has a proven track record of helping leverage
• Excellent analytical and critical thinking skills with heavy attention to detail, and the ability to focus on big-picture issues and use creativity to resolve issues and streamline processes
• Effective written and verbal communication skills to translate technical solutions and methodologies to executive leadership
• Excellent interpersonal and communication skills; team player
• An understanding of the demands and tight deadlines of a complex, marketing-driven organization
• Ability to work in a diverse environment with all levels of employees
• Ability to write reports that are understandable regardless of the financial knowledge of the audience

Travel Requirements

Travel up to 10%

LI-MN1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13417

Pay Grade : US-C15

Salary Range : $32.50 - $51.83

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

Job Description

KARL STORZ is currently seeking a highly motivated Data Analyst to join the Operations team. Reporting to the lead analyst of Customer Experience, the ideal candidate has expertise in Tableau visualization and is passionate about creating business value through designing and developing robust and performant data models.

Collaborating across customer support, technical services, logistics, compliance, OR1, and other business teams, this position will design and implement datasets and reports in Tableau, as well as perform analysis and share underlying trends and actionable insights to help our stakeholders in decision-making.

This opportunity will get you working on large-scale structured, unstructured data sets, and apply various data engineering and modeling techniques on real-world datasets to build and deploy models.

A well-qualified candidate should be highly technical with strong business acumen. They are a self-starter with abundant intellectual curiosity who excels at framing problems analytically, are comfortable working through ambiguity, and have a proven track record of helping leverage analytical insights to drive impactful decisions.

Responsibilities

• Collaborate with internal business partners facilitating the design, build, and automation of reports / dashboards in Tableau that provide actionable insight into customers, products, and sales force.
• Mine data, perform quantitative analysis, and create clear and actionable narratives about our customers, their behaviors, and drivers of retention and engagement.
• Leverage data modeling, wrangling, and analytics techniques to investigate our internal data and external data (e.g., surgical procedures) to boost our understanding of the medical devices market.
• Partner with compliance teams to understand the business context, develop metrics to measure performance and iterate and improve on data insights and solutions to deliver actionable information to the business.
• Collaborate with stakeholders including technical services, logistics, compliance, OR1 customer service, etc. on initiatives that improve our company-level KPIs and match our business priorities.
• Develop and deploy solutions for solving business problems with predictive modeling techniques.
• Build intuitive interfaces, infographics, and visualizations to tell stories with data.
• Create presentations with analysis and insights for both technical and non-technical audiences.
• Be constantly curious and continue to pursue in-depth explorations of our datasets.
• Communicate complicated data findings in a clear and concise manner to stakeholders.
• Ad-hoc analysis to address urgent high-impact analysis for business stakeholders

Required Qualifications

• A Bachelor's degree in a quantitative discipline (e.g., Statistics, Computer Science, Math, Engineering) or equivalent consulting experience.
• 3+ years of experience with data exploration and visualization like Tableau, PowerBI, etc. It is a plus if you can share a portfolio of clear, intuitive, and insightful visualizations.
• 3+ years of experience in data analytics, including building and deploying enterprise-wide data models with applications to real-world problems.
• Effective written and verbal communication skills to translate technical solutions and methodologies to executive leadership.
• Demonstrated success working in a collaborative, service-oriented team environment.
• Experience working in a cross-functional setting, managing the full lifecycle of projects.
• Experience working well with ambiguity, prioritizing needs, and delivering results in a dynamic environment.
• Attention to detail with self-discipline and a drive for results.
• Advanced problem-solving, organizational, analytical, and critical thinking skills.
• Proven experience with tolerance for ambiguity working through incubation to actual product definition.
• Pragmatic attitude and ability to rapidly iterate and evolve ideas into practical implementations.
• Proficient in SQL and / or other data query languages. Experience in handling large-scale data with efficiency. Familiarity with Python or R is a plus.
• Experience in the medical device or healthcare industry is a plus.
• Experience in process management or Celonis is a plus.

Join a dynamic team with a remote work policy that allows the flexibility to work four days from home and one day in the office.

LI-AA1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13417

Pay Grade : US-C15

Salary Range : $32.50 - $51.83

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

Job Description

KARL STORZ is currently seeking a highly motivated Data Analyst to join the Operations team. Reporting to the lead analyst of Customer Experience, the ideal candidate has expertise in Tableau visualization and is passionate about creating business value through designing and developing robust and performant data models.

Collaborating across customer support, technical services, logistics, compliance, OR1, and other business teams, this position will design and implement datasets and reports in Tableau, as well as perform analysis and share underlying trends and actionable insights to help our stakeholders in decision-making.

This opportunity will get you working on large-scale structured, unstructured data sets, and apply various data engineering and modeling techniques on real-world datasets to build and deploy models.

A well-qualified candidate should be highly technical with strong business acumen. They are a self-starter with abundant intellectual curiosity who excels at framing problems analytically, are comfortable working through ambiguity, and have a proven track record of helping leverage analytical insights to drive impactful decisions.

Responsibilities

• Collaborate with internal business partners facilitating the design, build, and automation of reports / dashboards in Tableau that provide actionable insight into customers, products, and sales force.
• Mine data, perform quantitative analysis, and create clear and actionable narratives about our customers, their behaviors, and drivers of retention and engagement.
• Leverage data modeling, wrangling, and analytics techniques to investigate our internal data and external data (e.g., surgical procedures) to boost our understanding of the medical devices market.
• Partner with compliance teams to understand the business context, develop metrics to measure performance and iterate and improve on data insights and solutions to deliver actionable information to the business.
• Collaborate with stakeholders including technical services, logistics, compliance, OR1 customer service, etc. on initiatives that improve our company-level KPIs and match our business priorities.
• Develop and deploy solutions for solving business problems with predictive modeling techniques.
• Build intuitive interfaces, infographics, and visualizations to tell stories with data.
• Create presentations with analysis and insights for both technical and non-technical audiences.
• Be constantly curious and continue to pursue in-depth explorations of our datasets.
• Communicate complicated data findings in a clear and concise manner to stakeholders.
• Ad-hoc analysis to address urgent high-impact analysis for business stakeholders

Required Qualifications

• A Bachelor's degree in a quantitative discipline (e.g., Statistics, Computer Science, Math, Engineering) or equivalent consulting experience.
• 3+ years of experience with data exploration and visualization like Tableau, PowerBI, etc. It is a plus if you can share a portfolio of clear, intuitive, and insightful visualizations.
• 3+ years of experience in data analytics, including building and deploying enterprise-wide data models with applications to real-world problems.
• Effective written and verbal communication skills to translate technical solutions and methodologies to executive leadership.
• Demonstrated success working in a collaborative, service-oriented team environment.
• Experience working in a cross-functional setting, managing the full lifecycle of projects.
• Experience working well with ambiguity, prioritizing needs, and delivering results in a dynamic environment.
• Attention to detail with self-discipline and a drive for results.
• Advanced problem-solving, organizational, analytical, and critical thinking skills.
• Proven experience with tolerance for ambiguity working through incubation to actual product definition.
• Pragmatic attitude and ability to rapidly iterate and evolve ideas into practical implementations.
• Proficient in SQL and / or other data query languages. Experience in handling large-scale data with efficiency. Familiarity with Python or R is a plus.
• Experience in the medical device or healthcare industry is a plus.
• Experience in process management or Celonis is a plus.

Join a dynamic team with a remote work policy that allows the flexibility to work four days from home and one day in the office.

LI-AA1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13498

Pay Grade : US-C16

Salary Range : $75,700 - 135,250

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ is a market leader in minimally invasive surgery and surgical visualization technologies. The Senior Data Analyst, OR1 will lead continuous improvement in the following areas of focus : OR1 Installation, Service, and Production and will support special projects.

OR1 is the high-tech commercial vertical of KARL STORZ, with hardware and software portfolios that drive Operating Room workflow efficiencies.

OR1 is a foundation of operating room infrastructures and leads in next-gen technologies.

The incumbent will be a core business partner and provide insight into the OR1 business and how to increase profitability by providing decision support, recommending process improvements, identifying new revenue opportunities, creating new metrics, and creating dashboards.

Additionally, he / she will be expected to provide ad-hoc analysis and relevant subject matter expertise.

We are seeking someone who lives for and LOVES data analytics and high tech for one of our faster growing divisions. Please click here to see a two minute video of our OR1 Division.

https : / / www.karlstorznetwork1.com / videos / clinician-and-patient-connectivity

Duties and responsibilities :

Production :

• Partner with key stakeholders to understand their business needs
• Lead cross-functional teams in the development of advanced analytics that identify operational improvements and efficiencies.
• Drives data mapping for manufacturing dashboards

Deployment Services :

• Bridge operations and finance to help maximize financial results
• Creating an OR1 Installation Dashboard by WBS / Project both for in-process and completed deals showing Actual and Plan Revenue and COS split by Material, Labor, and Travel by collaborating with OR1 Operations
• Use analysis to provide data-based recommendations, reports, and presentations including lessons learned from past deals and actual results
• Identifies metrics to manage field services teams in real-time using data analytics
• Identifies metrics / levers impacting the profitability of field services teams
• Tracks HR metrics that impact profitability and interrupt data to assist in the remediation

Project Success :

• Maximize return on investments by understanding the life of a project and what impacts a project's gross profit
• Track projects' success after the implementation is completed.
• Identifies analytics leading indicators that impact project GP

Service :

• Use data analytics to understand OR1 Service and develop new strategies to drive growth in the Service
• Understands data to be mined from the service ticketing system, and pulls data to create KPI dashboards on first-time fix rate, response time, field work order status, etc.
• Tracks HR metrics that impact profitability in service
• Model new ways for service delivery

Other Business Support :

• Build intuitive interfaces, infographics, and visualizations to tell stories with data.
• Create presentations with analysis and insights for both technical and non-technical audiences and present and interact with executives.
• Become a subject matter expert on the process and tools used within KARL STORZ
• Lead the analysis of new acquisition models, like XaaS
• Lead competitive market analysis preparation
• Lead development of sales metrics and business planning for the business unit.
• True business partner to Executive Management, looking for the story in the data, and assisting with executive readouts (such as QBRs).
• Systems super user : Understanding how data flows between SAP, Project Systems, HRIS, and Service Ticketing Systems.
• Completes other special projects as assigned.

Qualifications :

Education / Experience

• Bachelor's degree in a quantitative discipline (e.g., Statistics, Computer Science, Math, Engineering) or equivalent consulting experience); MBA preferred;
• 5+ years of experience with data exploration and visualization like Tableau, Looker, PowerBI, etc
• 3+ years of experience in data analytics, including building and deploying enterprise-wide data models with applications to real-world problems

Skills / Characteristics

• A well-qualified candidate should be highly technical with strong business acumen
• Self-starter with abundant intellectual curiosity who excels at framing problems analytically, is comfortable working through ambiguity, and has a proven track record of helping leverage
• Excellent analytical and critical thinking skills with heavy attention to detail, and the ability to focus on big-picture issues and use creativity to resolve issues and streamline processes
• Effective written and verbal communication skills to translate technical solutions and methodologies to executive leadership
• Excellent interpersonal and communication skills; team player
• An understanding of the demands and tight deadlines of a complex, marketing-driven organization
• Ability to work in a diverse environment with all levels of employees
• Ability to write reports that are understandable regardless of the financial knowledge of the audience

Travel Requirements

Travel up to 10%

LI-MN1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13255

Pay Grade : US-C17

Salary Range : $84,800 - $135,250

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ Endoscopy-America, Inc. (KSEA) has launched an initiative toward continuous improvement and efficiency. Some elements of this initiative are grassroots in nature, and others are strategic.

To embed the culture of Continuous Improvement and Lean / Six Sigma skillsets, the KSEA organization will need to hire this background and experience.

The Continuous Improvement Manager will serve as a member of the Value Delivery Office based in El Segundo, CA. This role reports to the Director, Value Delivery Office.

To be successful, this individual must :

• Lead the development of a Lean mindset within the partner business function
• Lead development of core value stream and process mapping
• Identify the most impactful opportunity(s) for efficiency and sales velocity gains within the partner business function
• Work with sponsors and VDO project manager to go from opportunity identification to project scoping to change sustainment
• Codevelop KPIs and implement visual management
• Establish standard work and root cause analysis approaches within partner functions

Skills

• Ability to establish and maintain strong relationships with all levels of the organization
• Ability to influence others and move toward a common vision or goal
• Demonstrated experience of success through perseverance
• Ability to self-develop and execute a strategic plan
• Strong business acumen and understanding of organizational issues and challenges
• Familiarity with project management approaches, tools, and phases of the project lifecycle

Qualifications

• BS / BA required
• Six Sigma Green Belt
• 7+ years relevant work experience with involvement in, or leading of, continuous improvement programs, including in commercial (e.

g., non-manufacturing) functions

• Demonstrated experience with leading value stream mapping
• Demonstrated experience implementing and leading visual management
• Healthcare, medical device, or a related industry experience preferred
• Prior experience working with global organizations preferred

LI-CW1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13465

Pay Grade : US-D18

Salary Range : $95,000 - $151,500

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ is currently searching for a Regulatory Intelligence Manager who will assure that all information for a worldwide approval or registration for the assigned products and projects is available.

This position will be responsible for ensuring state-of-the-art requirements, defined by regulatory bodies, are included in the new product development or product change for the assigned products;

ensuring all global approvals and conformity assessment processes meet current regulatory requirements (support enhancements / updates as required) and assist in meeting all Regulatory compliance objectives.

Responsibilities

• Prepare products for regulatory release.
• Identify, analyze, interpret, and communicate relevant global regulations and technical standards that apply to the assigned products and projects , including compilation of information from :

Global Regulatory Assessments

• Published regulations and standards (e.g., FDA, MDR, RoHS, ISO, EN, IEC, ASTM)
• Published guidance documents
• Draft regulations and standards
• Regulatory and certification agency interpretations
• KARL STORZ policies and procedures
• Ensure new products meet requirements of applicable regulations and standards (State of the Art). Work with product development teams from product conception through development and during entire product lifecycle to accomplish the following :

Identify applicable standards, including electrical safety, EMC, sterility assurance, material compatibility, software, etc.

• Ensure inclusion of specific regulatory and standard requirements in product specifications
• Analyze proposed solutions and / or required components and construction
• Collaborate with the risk management team; assess risks, review mitigation measures, evaluate residual risks.

Perform subsequent audit of risk mitigation measures.

• Review test plans and design verification / validation reports
• Ensure adherence to labeling requirements as dictated by global regulatory agencies and KARL STORZ requirements (product, Instruction manual / card, shipping box, etc.)
• Perform Phase Gate Reviews (Design History File reviews) and product release
• Coordinate document submissions to KSEA and KST Regulatory departments for :

US 510k & PMA submissions

• EU Technical File compilation and CE Marking
• Other international registrations and approvals
• Assure the assigned products meet the certifications requirements to relevant standards.

Support. Provide medical electrical equipment safety (IEC60601-1) and medical electrical equipment electromagnetic compatibility (IEC60601-1-2) when applicable

Ensure appropriate controls for Engineering Change process, including :

Change control for PMA devices and / or 510k devices

• Safety agency review / approval for changes to safety critical components
• Liaison to Regulatory Affairs Material compliance group for RoHS compliance of changes to components and finished products
• Provide audit support as needed for quality systems audits (TUV, FDA, Inter-Corporate, etc.). Support resolution of internal / external audit findings related to Regulatory Compliance.
• Participate in investigation and resolution of customer complaints and CAPAs, as needed.
• Participate as a member of continuous improvement projects / teams seeking ways to improve the quality of KSE's products and services.
• Participate and influence US National Standards Committees as requested in coordination with Corporate Regulatory Compliance.
• Perform other related duties as assigned by supervisor
• Regular attendance is an essential job function

Requirements

• Bachelor's degree in Engineering or related technical field with 7+ years' experience in medical device regulatory compliance or Master's degree in Engineering or related technical field with 5+ years of experience in medical device regulatory compliance.
• Knowledge and experience working with electro-mechanical software driven medical devices.
• Knowledge of EU Directives, particularly; MDR, Machinery Directive, EMC Directive and Low Voltage Directive.
• Familiarity with Medical Device Compliance guidance / standards - EMC ( e.g. IEC / EN 60601-1-2) and Electrical safety (e.

g. IEC / EN 60601-2-18), Software (e.g. IEC / EN 62304), Biocompatibility (e.g. EN / ISO 10993 series), Sterilization (e.

g. EN / ISO 113X), Labeling (e.g. EN / ISO 15223), etc.

• Knowledge of medical device quality system regulations and standards (e.g. EN / ISO 13485, FDA QSR, MDSAP, etc),
• Understanding the application of Risk Management principles (e.g. EN / ISO 14971)
• Excellent written and oral communication skills.
• Results oriented, and ability to manage multiple projects simultaneously
• Proven ability with Word Processing, Excel, Visio and other Microsoft Office applications
• Ability to travel to other KS sites globally (10-20%)

Preferences

• Experience with SAP preferred.
• Experience in Project Management preferred.
• Experience in KARL STORZ structures and business acumen preferred

LI-CW1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13465

Pay Grade : US-D18

Salary Range : $95,000 - $151,500

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ is currently searching for a Regulatory Intelligence Manager who will assure that all information for a worldwide approval or registration for the assigned products and projects is available.

This position will be responsible for ensuring state-of-the-art requirements, defined by regulatory bodies, are included in the new product development or product change for the assigned products;

ensuring all global approvals and conformity assessment processes meet current regulatory requirements (support enhancements / updates as required) and assist in meeting all Regulatory compliance objectives.

Responsibilities

• Prepare products for regulatory release.
• Identify, analyze, interpret, and communicate relevant global regulations and technical standards that apply to the assigned products and projects , including compilation of information from :

Global Regulatory Assessments

• Published regulations and standards (e.g., FDA, MDR, RoHS, ISO, EN, IEC, ASTM)
• Published guidance documents
• Draft regulations and standards
• Regulatory and certification agency interpretations
• KARL STORZ policies and procedures
• Ensure new products meet requirements of applicable regulations and standards (State of the Art). Work with product development teams from product conception through development and during entire product lifecycle to accomplish the following :

Identify applicable standards, including electrical safety, EMC, sterility assurance, material compatibility, software, etc.

• Ensure inclusion of specific regulatory and standard requirements in product specifications
• Analyze proposed solutions and / or required components and construction
• Collaborate with the risk management team; assess risks, review mitigation measures, evaluate residual risks.

Perform subsequent audit of risk mitigation measures.

• Review test plans and design verification / validation reports
• Ensure adherence to labeling requirements as dictated by global regulatory agencies and KARL STORZ requirements (product, Instruction manual / card, shipping box, etc.)
• Perform Phase Gate Reviews (Design History File reviews) and product release
• Coordinate document submissions to KSEA and KST Regulatory departments for :

US 510k & PMA submissions

• EU Technical File compilation and CE Marking
• Other international registrations and approvals
• Assure the assigned products meet the certifications requirements to relevant standards.

Support. Provide medical electrical equipment safety (IEC60601-1) and medical electrical equipment electromagnetic compatibility (IEC60601-1-2) when applicable

Ensure appropriate controls for Engineering Change process, including :

Change control for PMA devices and / or 510k devices

• Safety agency review / approval for changes to safety critical components
• Liaison to Regulatory Affairs Material compliance group for RoHS compliance of changes to components and finished products
• Provide audit support as needed for quality systems audits (TUV, FDA, Inter-Corporate, etc.). Support resolution of internal / external audit findings related to Regulatory Compliance.
• Participate in investigation and resolution of customer complaints and CAPAs, as needed.
• Participate as a member of continuous improvement projects / teams seeking ways to improve the quality of KSE's products and services.
• Participate and influence US National Standards Committees as requested in coordination with Corporate Regulatory Compliance.
• Perform other related duties as assigned by supervisor
• Regular attendance is an essential job function

Requirements

• Bachelor's degree in Engineering or related technical field with 7+ years' experience in medical device regulatory compliance or Master's degree in Engineering or related technical field with 5+ years of experience in medical device regulatory compliance.
• Knowledge and experience working with electro-mechanical software driven medical devices.
• Knowledge of EU Directives, particularly; MDR, Machinery Directive, EMC Directive and Low Voltage Directive.
• Familiarity with Medical Device Compliance guidance / standards - EMC ( e.g. IEC / EN 60601-1-2) and Electrical safety (e.

g. IEC / EN 60601-2-18), Software (e.g. IEC / EN 62304), Biocompatibility (e.g. EN / ISO 10993 series), Sterilization (e.

g. EN / ISO 113X), Labeling (e.g. EN / ISO 15223), etc.

• Knowledge of medical device quality system regulations and standards (e.g. EN / ISO 13485, FDA QSR, MDSAP, etc),
• Understanding the application of Risk Management principles (e.g. EN / ISO 14971)
• Excellent written and oral communication skills.
• Results oriented, and ability to manage multiple projects simultaneously
• Proven ability with Word Processing, Excel, Visio and other Microsoft Office applications
• Ability to travel to other KS sites globally (10-20%)

Preferences

• Experience with SAP preferred.
• Experience in Project Management preferred.
• Experience in KARL STORZ structures and business acumen preferred

LI-CW1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.