Role OverviewThe Principal Design Quality Engineer I plays a central role in ensuring that our in-vitro diagnostic products are safe, effective, compliant, and built on robust design principles. You will partner closely with R&D, Systems Engineering, Regulatory Affairs, and Manufacturing to guide products through the full design and development lifecycle, from concept through commercialization and post-market support.
What You Will Do
Serve as the Design Quality representative on cross-functional product development teams, ensuring compliance with 21 CFR 820, ISO 13485, IVDR, and other applicable standards. Lead and maintain Design Control activities, including design plans, design reviews, risk management files, verification/validation strategy, and design transfer documentation.
Why It Might Be a Fit
Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVD-specific regulatory expectations. Experience with risk management, verification/validation, and design documentation. Ability to interpret engineering drawings, specifications, and test data.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related technical field.
- 3–7+ years of experience in medical device or IVD product development, with direct involvement in design controls.
Benefits
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices
- Company subsidized cafeteria in our Waltham, MA office
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