Hiring: Principal Design Quality Engineer I Company: Nova Biomedical Location: Waltham, MA Job Posted Time: 2026-09-03 10:18:46 Employment Type: Hybrid Target Skills & Keywords : R About the job Experience: •7+ years of experience in medical device or IVD product development, with direct involvement in design controls. Required Skills: •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. Qualifications: •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. •Demonstrated capacity to interpret engineering drawings, specifications, and test data. •Excellent communication skills and comfort working cross-functionally. •Operational familiarity with IVDR requirements preferred. •Background in statistics, DOE, or analytical method validation preferred. •Able to stand or sit for extended periods. •Occasional bending, reaching, or movement within lab environment. •Able to use required personal protective equipment (PPE). Compensation: •$120,000 - $160,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!