Principal Design Quality Engineer

Principal Design Quality EngineerLocation: Minneapolis-St. PaulCompensation: $145,000-$165,000 with benefits, bonus, LTI, based on experienceThis role serves as the quality lead for medical device product development, ensuring new products are designed, tested, and transferred to manufacturing in compliance with FDA regulations and international quality standards.Key responsibilities include:Partnering with R&D teams throughout the product development processLeading design quality activities such as risk management, FMEAs, and design controlsReviewing and approving verification and validation (V&V) testing plans, protocols, and reportsProviding quality oversight for biocompatibility, sterilization, packaging, shelf-life, and test method validation activitiesSupporting supplier qualification, incoming inspection, and manufacturing readiness for new product launchesEnsuring Design History Files (DHFs) and Risk Management Files remain complete and audit-readySupporting design transfer, process validation (IQ/OQ/PQ), and manufacturing scale-up effortsParticipating in FDA, ISO 13485, and Notified Body audits and inspectionsContributing to regulatory submissions, including 510(k), PMA, and CE Mark documentationActing as a technical leader and mentor for other quality engineersIdeal background10+ years of medical device quality engineering experienceStrong expertise in Design Controls, Risk Management (ISO 14971), FMEA, V&V, and Test Method ValidationDeep understanding of FDA QSR/QMSR, ISO 13485, and EU MDR requirementsExperience with Class II or III medical devices, preferably cardiovascular, catheter, or other interventional productsStrong statistical analysis and technical documentation skillsExperience supporting audits, regulatory submissions, and product commercialization