Job Summary: Nova Biomedical is seeking a
Principal Design Quality Engineer I to support the development of innovative, high-performance diagnostic and analytical technologies used in clinical care, critical care, bioprocessing, and life science research. This role plays a central part in ensuring Nova Biomedical's in-vitro diagnostic products are safe, effective, compliant, and built on robust design principles.
The Principal Design Quality Engineer I 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.
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 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/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, with a focus on design-related processes.
- Participate in internal and external audits, providing subject matter expertise on design controls and IVD product development.
Experience Requirements: - Bachelor's degree in Engineering, Life Sciences, or a related technical field required.
- 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/validation, and design documentation.
- Ability to interpret engineering drawings, specifications, and test data.
- Excellent communication skills and comfort working cross-functionally.
- Experience with IVD assays, instrumentation, software-driven diagnostics, or reagent/consumable development.
- Familiarity with IVDR requirements preferred.
- Background in statistics, DOE, or analytical method validation preferred.
- Experience in a fast-paced, early-stage, or growth-stage biotech environment preferred
Physical Requirements and Working Conditions: - Able to stand or sit for extended periods.
- Occasional bending, reaching, or movement within lab environment.
- Able to use required personal protective equipment (PPE).
- Willingness to work in a laboratory environment with exposure to chemicals or biological materials.
- Comfort with performing repetitive tasks.
- Capacity to lift and carry up to 25 pounds.
- Manual dexterity required for handling laboratory equipment and instrumentation.
Why work for Nova Biomedical - 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
Work Location: Hybrid work schedule on-site in Waltham, MA
Targeted Salary Range: $120,000 - $160,000/year.
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
