Principal Design Quality Engineer I

Nova Biomedical Corporation • Waltham, MA

1d • Hybrid

About The Position

The 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. This role is ideal for someone who thrives at the intersection of engineering rigor, quality systems, and hands-on problem solving.

Requirements

• 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.
• Excellent communication skills and comfort working cross-functionally.
• 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.

Nice To Haves

• Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development.
• Familiarity with IVDR (EU 2017/746) 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, 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.
• Develop, review, and approve risk management documentation (per 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/preventive actions (CAPA) 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, with a focus 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, & 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal