Principal Design Quality Engineer I
About The Position
Nova Biomedical is seeking a Principal Design Quality Engineer I to support development of diagnostic and analytical technologies for clinical care, critical care, bioprocessing, and life science research. The role helps ensure in-vitro diagnostic products are safe, effective, compliant, and supported by robust design principles. The engineer partners with R&D, Systems Engineering, Regulatory Affairs, and Manufacturing throughout the design and development lifecycle, from concept through commercialization and post-market support. The role combines engineering rigor, quality systems expertise, and practical problem-solving.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 3–7+ years of experience in medical device or IVD product development, with direct involvement in design controls.
- Strong working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IVD-specific regulatory expectations.
- Experience with risk management, verification and validation, and design documentation.
- Ability to interpret engineering drawings, specifications, and test data.
- Excellent communication skills and comfort working cross-functionally.
Nice To Haves
- Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development.
- Familiarity with IVDR requirements.
- Background in statistics, DOE, or analytical method validation.
- Experience in a fast-paced, early-stage, or growth-stage biotech environment.
Responsibilities
- Serve as the Design Quality representative on cross-functional product development teams and ensure 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 and validation strategy, and design transfer documentation.
- Develop, review, and approve risk management documentation in accordance with ISO 14971, including hazard analyses, FMEAs, and risk-benefit assessments.
- Partner with R&D to ensure design inputs are clear, testable, and aligned with user needs and regulatory expectations.
- Review and approve engineering documentation such as specifications, test protocols, test reports, and design changes.
- Support verification and validation activities, including method development, statistical justification, and traceability.
- Drive root cause investigations and corrective and preventive actions related to design issues, nonconformances, and field performance.
- Support supplier quality activities for design-critical components, including qualification and change assessments.
- Contribute to continuous improvement of the Quality Management System, focusing on design-related processes.
- Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development.
Benefits
- Flexible medical, dental, and vision coverage
- Competitive 401(k) 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 at the Norwood, Billerica, and Westbrook offices
- Company-subsidized cafeteria at the Waltham office
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What This Job Offers
Job Type
Full-time
Career Level
Principal
