Design Quality Engineer

Responsibilities:Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.Support sterilization and biocompatibility assessments.Own and maintain design control documentation.Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.Maintain accurate test, validation, and risk records and report progress to leadership.Support regulatory submissions (e.g., 510(k), CE Mark).Lead root cause investigations and corrective actions related to design issues.Support complaint investigations, nonconformances, and CAPAs after product launch.Conduct DHF audits to ensure phase completion requirements are met.Review and approve engineering documents and test reports.Identify opportunities to improve product quality, reduce cost, and increase efficiency.RequirementsBachelor's degree in Engineering or related field.10+ years of quality engineering experience in medical devices, including new product launches.Experience with sterilization and biocompatabilityStrong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).Experience with verification & validation (V&V) and FMEAs.Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).Detail-oriented with strong documentation skills.Quality certifications (CQE, CSQE, Six Sigma) are a plus.