The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.

We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.

Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Manager, Manufacturing. Under minimal supervision, this position is responsible for management of manufacturing, assembly, and production departments and personnel by providing guidance, training and leadership on a daily basis.

Position may be part of multi-shift supervisor team empowered to manage 24 hour manufacturing operations.

This position will be located onsite in San Diego, CA.

The Responsibilities

Responsible for managing and monitoring assembly preparation, device assembly, meter preparation and calibration, and / or packaging areas

Establishes manufacturing policies and procedures

Develops and recommends project objectives, timelines and resources, and prepares cost estimates

Manages departmental budgets and spending

Uses problem analysis techniques to resolve production-related, technical, regulatory, quality, and supply issues

Represents the department or leads cross-functional teams aimed at resolving issues, and implementing projects.

Reviews complaints and suggestions, and recommends methods or techniques for improvement

Ensures personnel are trained and qualified in manufacturing procedures

Demonstrates commitment to the development, implementation and effectiveness of Quidel’s GMP, LEAN, and Safety programs.

Ensures compliance with FDA, ISO, OSHA, and other regulatory agencies

Manages performance of staff towards department and Company goals, including but not limited to feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance.

Carries out duties in compliance with established business policies

Performs other duties & projects as assigned

The Individual

Required Skills : High School Diploma

High School Diploma

Eight years of experience in manufacturing required, preferably in the biotechnology industry

Excellent skills in MS Office (MS Word / Excel)

Excellent Good Manufacturing Practice (GMP) knowledge

Experience in understanding and adhering to manufacturing documentation, and completing manufacturing documentation

Experience in managing the operation of equipment and conduct tasks in a safe manner, adhering to established guidelines and applicable regulations

Strong technical writing and analytical skills required to write investigative reports, SOPs, NCMRs, batch records and other production-related documents

Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies

Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Preferred Skills :

Bachelor’s degree in production, life science or equivalent or a combination of courses and experience

Four years of experience in a management position overseeing supervisors and staff

The Key Working Relationships

Internal : R&D, Supply Chain, Production Managers, Planning, Cost Accounting, Facilities ,Process Engineers and Quality Engineers.

External : Supplier, Vendors and contractors

The Work Environment

The work environment characteristics are representative of office, laboratory, and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples.

Flexible work hours to meet project deadlines.

Position requires ability to lift up to 30 lbs. on occasion. Up to 60% of time in meetings, working with team and on the manufacturing floor;

40% of the time at the desk on computer, walking, standing or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role.

Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data.

At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case.

The salary range for this position is $85,000.00 - 150,000.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Education

• Engineering Degree, Manufacturing Duties / Responsibilities The Process Engineer provides key technical support to manufacturing through;
• Using engineering methods to investigate, analyze and upgrade manufacturing processes, methods, technology, and / or equipment in order to maximize production efficiencies, reduce costs and improve product quality.
• Development and deployment of technology that supports improved processes understanding and product innovation.
• Optimization of process controls with consideration of value contribution.
• Supporting continuous improvement initiatives such that they become entrenched in the company’s culture and operations.
• RESPONSIBILITIES : Partnering with internal customers to improve production processes & process knowledge of operators.
• Utilization of SPC and advanced problem solving tools and the delivery of education and competency to colleagues.
• Standardization of work.
• Managing resources appropriately to develop specialized knowledge that impacts product quality and efficiency.
• Design and implementation of adopted cost savings suggestions relative to processing and / or plant equipment.
• Work collaboratively with internal customers, engineering, commercial teams on new product development projects and their implementation within operations.

This could include the commissioning of capital assets in conjunction with Project Leaders and others.

• Liaise with all parties to co-ordinate project scheduling and execution.
• Actively participate and support all safety initiatives within the manufacturing location.
• REQUIRED SKILLS AND ABILITIES : Degree in Engineering relatable to Manufacturing.
• Solid knowledge of statistical process control and its application, project management, time management and computer programming tools (Solidworks, Auto CAD, Excel, Word, Minitab, ERP).
• Experience with Continuous Improvement.
• Other skills required : teamwork, collaboration, planning, organizing, customer service orientation, analysis, problem assessment, problem solving, innovation, and creativity.

Description

Overview

Teledyne API (TAPI), a business unit within the Environmental and Electronic Measurement Instruments group within Teledyne Technologies Incorporated (NYSE : TDY), continues to be the global leader in the manufacturing of advanced instrumentation for monitoring of atmospheric pollution.

We design, manufacture and market precision gas analyzers and air quality monitoring products both domestically and internationally.

Teledyne is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, gender, sexual orientation, gender identity, gender expression, transgender, pregnancy, marital status, national origin, ancestry, citizenship status, age, disability, protected Veteran Status, genetics or any other characteristic protected by applicable federal, state, or local law.

JOB SUMMARY

This position reports to the Technical Support Supervisor and plays a key role in the assistance of the Technical Support and Production Departments.

This position will also interface with customers to provide assistance and technical troubleshooting of SO2, TRS, H2S, NOX, NO, NO2, NH3, O2, O3, CO, CO2, N2O gas instrumentation, and PM10, PM2.

5 particulate instrumentation. This position will begin within the Customer Service / Repair Lab as part of the training progression towards potentially an Engineering Technician role within the Technical Support Center.

ESSENTIAL JOB DUTIES

• Will provide customer assistance by repairing, advising on the repair and use, and factory repair of API analyzers and associated equipment used in their operation.
• Works on assignments that are semi-routine in nature but recognizes the need for occasionally deviation from accepted practice.
• Electronic troubleshooting and resolving problems in both software-controlled Analog and Digital surface mount circuit boards.
• Responsible for solving start-up and calibration problems and repairing instruments for the assigned products.

QUALIFICATIONS

• Associates degree in a mechanical related field or equivalent work experience with air pollution instrumentation and / or other mechanical / electro-mechanical machinery.
• 3-5 years of experience and / or education in a service-related environment, particularly oriented toward electronic, pneumatic and electromechanical instrumentation.
• Must have experience using the following test equipment : VOM, oscilloscopes, recorders, hand tools, test jibs and custom test equipment as required.
• Must be able to exercises judgment within defined procedures and practices to determine appropriate action.
• Must be able to communicate and articulate professionally and clearly both verbally and in writing.
• Must possess problem solving skills, strong digital and analog skills, and the ability to troubleshoot in a logical manner with high attention to detail.
• Requires general computer skills and knowledge of Word, Excel and Power Point programs.
• Excellent interpersonal skills required for customer and team interaction -Environmental Industry product knowledge, a plus.
• Experience with Microsoft AX and Salesforce a plus.

PHYSICAL REQUIREMENTS

• This position will require travel within and outside of the United States 10% of the time.
• This position will involve repetitive work utilizing hand tools, a computer, keyboard, and mouse 75% of the time.
• The position will require frequent sitting, reaching, twisting, turning, standing, stooping, bending, pushing, pulling, walking, turning, and twisting.

California Pay Transparency Statement

Please note the salary range posted below is a general guideline for this job level and location. When extending an offer, a variety of factors are considered such as responsibilities of the position, relevant education and experience, certifications, knowledge and skills.

Salary Range :

$41,800.00 - $69,850.00

Teledyne and all of our employees are committed to conducting business with the highest ethical standards. We require all employees to comply with all applicable laws, regulations, rules and regulatory orders.

Our reputation for honesty, integrity and high ethics is as important to us as our reputation for making innovative sensing solutions.

Teledyne is an Equal Opportunity / Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age, or any other characteristic or non-merit based factor made unlawful by federal, state, or local laws.

ABOUT Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech.

We are developing an automated, benchtop diagnostic system to provide lab-accurate results in 20 minutes for a comprehensive suite of health tests.

Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.

Our work at Truvian is more than a job It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to putting health information where it belongs - in the hands of the individual.

We are partners in the belief that talented people, working as a team, can make every day an adventure. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers! JOB SUMMARY We are seeking a talented and experienced Manufacturing Engineer 3 or Senior Manufacturing Engineer to join the Manufacturing Engineering team.

Candidates demonstrating increasing responsibility and direct experience in diagnostic consumables manufacturing within the life sciences industry will be considered.

The scope of the role includes but is not limited to, the hands-on design, modification, characterization, and ultimate qualification of production processing equipment and sustaining supporting processes in manufacturing diagnostics consumables.

These consumables include an injection molded disc, reagent cartridge, and a microfluidic sub-system component, some of the consumables utilized within Truvian’s platform.

The individual filling this role will work closely with consumable design engineers, automation design engineers, quality, technicians and operators, and other members of the broad organization.

The candidate needs strong communication skills to present concepts, experiments, and results to management and top leadership Since equipment qualification, process characterization, process optimization, and process validation are principal responsibilities of this position, strong attention to detail and clear and concise documentation protocol preparation and execution are required.

HERE’S WHY YOU’LL LOVE THIS JOB : You will be integral in launching the first core product for Truvian, which is a game changer! You'll work with a rock-star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products.

You’ll be a key player on a team responsible for the company’s growth and product launch. You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, and new processes, and make things happen quickly without a bunch of red tapes.

You’ll have great perks such as Generous Benefits (Medical / Dental / Vision / EAP / Paid Life Insurance / LTD / 401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on-site gym, and virtual classes, and a farm to table on-site restaurant including a 30% discount.

WHAT YOU WILL DO On-site role is responsible for constructing, executing, and evaluating controlled experiments (including DOE's) to optimize processes, address yield, and quality issues, and drive implementation of solutions into a production environment.

Analyze existing processes and identify areas for improvement, proposing and implementing solutions to enhance efficiency, reduce waste, and increase throughput.

Design and implement process control systems to monitor and optimize production parameters, ensuring consistent product quality and compliance with safety and regulatory standards.

Independently create and execute Equipment Qualification (IQ / OQ / PQ) and Process Validation (PV) protocols to qualify manufacturing processes.

Provide technical expertise and support to production teams, troubleshooting process-related problems, and implementing corrective actions.

Assist the manufacturing engineering team in developing, building, testing, and qualifying equipment as required. Communicate results and challenges with colleagues.

Interact with technical users of IVD systems to understand issues they observe. Lead or contribute to continuous improvement initiatives, such as Lean Manufacturing or Six Sigma projects, to drive operational excellence and optimize overall manufacturing performance.

WHAT YOU WILL BRING : Applicants should possess a Bachelor's degree, preferably in Life Sciences or Engineering, and a minimum of five years of industry experience in operations engineering.

Ideally, candidates would have exposure to life sciences, diagnostics, and / or medical devices gained from working in both small and large companies.

The ideal candidate will have extensive experience in : Achieving impossible timelines through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast.

Partnership and collaboration, ensuring relationships are at the forefront of our strategy, emphasizing the company and team over personal goals.

Demonstrate effective communication skills, both orally and in writing, by consistently and clearly conveying information to internal and external stakeholders.

Maintain timely communication to ensure alignment among all parties involved, enabling the delivery of impactful outcomes with efficiency.

Proficient in utilizing a wide range of tools, including experience in implementing and working with ERPs, Microsoft Office suite, and other essential software.

Proficient in problem-solving and equipped with powerful analytical skills, enabling proactive identification and resolution of issues.

Possesses a solution-oriented mindset and exceptional time management abilities. Self-motivated personality, capable of self-instruction and quality completion of projects with tight deadlines and under intermittent supervision.

Ability to quickly grasp complex technical, procedural, and regulatory concepts and apply them to assignments. Excellent verbal and written communication skills, including presentations to peers, leaders, and executives.

Previous experience in maintenance, preferably in medical devices or IVD product development, is strongly preferred. Direct experience in a GMP / ISO 13485-regulated manufacturing environment is highly desired.

Direct experience with Equipment Qualification (IQ / OQ / PQ) in an FDA Class II / III industry is highly desired. SUPERVISORY ROLE No SALARY RANGE $90,500 to $109,000 Manufacturing Engineer 3 $110,000 to 130,000 Sr.

Manufacturing Engineer This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to, experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.

Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.

PHYSICAL DEMANDS AND ABILITIES Regularly required to use hands to finger, handle or feel, reach with hands and arms, and talk or hear Ability to lift and move over 25 lbs.

repeatedly and safely, occasionally 75 lbs. with assistance Frequently required to stand, walk, stoop, kneel, crouch, or crawl Occasionally required to sit and climb or balance Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus If you want to stand out, please include a cover letter Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. Powered by JazzHR

Job Summary

General Atomics (GA), and its affiliated companies, is one of the world’s leading resources for high-technology systems development ranging from the nuclear fuel cycle to remotely piloted aircraft, airborne sensors, and advanced electric, electronic, wireless and laser technologies.

This manufacturing engineer is responsible for overseeing and improving manufacturing, assembly and testing for high power RF components and systems.

The position develops schedules and implements work activities for the manufacturing, assembly and testing of high power RF components and systems.

Coordinates day to day activities of the manufacturing process, including personnel guidance, work assignments, procurement and coordination of the product flow through the manufacturing phase.

Generates and executes policies and procedures and recommends modifications to operating policies.

DUTIES & RESPONSIBILITES

• Attends to day-to-day activities, generating technical documents, maintaining project schedules, and working closely with others on the technical team.
• Generates process flows, procedures, and interfaces with quality assurance personnel.
• Gives guidance to assemblers and technicians, through all phases of manufacturing in accordance with established schedules.

Schedules and coordinates work assignments.

• Interacts with vendors to ensure timely delivery of material and sub-components.
• Supports the fabrication, modification, installation, and documentation of complex laboratory, experimental or commercial equipment.
• Works with design engineers to resolve design and documentation issues.
• Seeks methods to maintain and improve product quality, repeatability and efficiency.
• Expected to work in a safe manner in accordance with established operating procedures and practices.
• Performs other duties as assigned or required.

We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.

Job Qualifications

Typically requires a bachelors degree, masters degree or PhD in engineering or a related technical discipline from an accredited institution and progressive engineering experience as follows;

six or more years of experience with a bachelors degree, four or more years of experience with a masters degree, or two or more years with a PhD.

May substitute equivalent engineering experience in lieu of education.

• Must demonstrate technical understanding of manufacturing, assembly and test concepts and practices, with the ability to schedule and coordinate workloads to meet established milestones.
• Must be customer focused and possess :
• The ability to identify issues, analyze and interpret data and develop innovative solutions to a variety of complex matters of diverse scope and nature;
• Excellent analytical, verbal and written communication skills to accurately document, report, and present findings to a variety of audiences including management;
• Excellent interpersonal skills to influence and guide all levels of employees;
• The ability to maintain the confidentiality of sensitive information;
• The ability to represent the company on external projects; and
• The ability to handle common computer tasks.
• Preferred but not required, knowledge of microwave systems, RF test equipment, vacuum systems, and / or complex machinery is a plus.