Senior Design Quality Engineer
$103,000–$145,000 year
On-siteCambridge, Massachusetts, United States or San Diego, California, United States
Job Summary
Oversee system and hardware quality and safety risk management throughout the product life cycle, providing independent oversight of design input, verification and validation, design transfer, and post-market performance. Act as the single point of contact for project teams to ensure hardware design meets quality and compliance standards for every milestone, performing independent technical assessments on product quality and post-market analysis. This office-based role requires full-time presence in company facilities, with a schedule of at least three in-person days per week for office teams.
Required Qualifications
- Bachelor's / Master's Degree in Mechanical Engineering, Electronics Engineering, Science or equivalent
- 2+ years of experience in product design as demonstrated by a role in quality, engineering, service, or manufacturing in a regulated environment with Medical Device experience
- US work authorization
- Reside in or within commuting distance to Bothell WA, Cambridge MA, Reedsville PA, Plymouth MN, San Diego CA
- Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position
Desired Qualifications
- 5+ years of experience preferred
- Experience with FMEAs and Product Safety Risk Management preferred
- Expertise in Application of Risk Management to Medical Devices (IEC 14971)
- Expertise in Medical Device Software Life Cycle Processes (IEC 62304)
- Application of Usability Engineering to Medical Devices (IEC 62366)
- 21CFR820
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