Manufacturing Engineer 3 / Senior Manufacturing Engineer
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