Principal Manufacturing Quality Engineer

Principal Manufacturing Quality EngineerJob OverviewOur client is an advanced structural heart company that is leading the industry through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. This innovative company is a developing a new cardiac device designed to mimic a healthy aortic valve.The Principal Manufacturing Quality Engineer will provide strategic manufacturing quality leadership supporting the development, clinical advancement, commercialization, and ongoing manufacturing of an implantable Class III medical device system.This role is focused on heart tissue processing, valve manufacturing, sterilization, and manufacturing process controls to ensure product compliance, safety, and scalability as the company advances toward commercialization.The person hired will play a critical role in ensuring quality systems and manufacturing controls across tissue processing and valve manufacturing operations.This position will partner with Manufacturing, R&D, Process Development, Operations, Regulatory, Clinical, and Supply Chain teams to support process development, validation, risk management, investigations, and continuous improvement activities.The ideal candidate brings industry expertise in manufacturing quality within regulated Class III medical devices, a strong knowledge of biological tissue processing, and demonstrated leadership capability with potential advancement into a Quality Manager role.Primary Duties and Responsibilities:Serve as the manufacturing quality subject matter expert for tissue processing, valve manufacturing, sterilization, and manufacturing process controls.You will partner with R&D, Process Development, Manufacturing Engineering, and Operations teams to develop and execute manufacturing quality strategies supporting tissue processing and finished device manufacturing.Lead process validation strategies, including IQ/OQ/PQ, TMV, software validation, and risk-based validation approaches for tissue processing and sterilization processes.Provide technical leadership in the characterization, evaluation, and control of pericardial tissue processing methods and associated manufacturing risks. Support development and commercialization of novel tissue processing and sterilization technologies.Lead or facilitate complex investigations involving nonconformances, CAPAs, process deviations, and manufacturing failures, ensuring timely root cause analysis and implementation of effective corrective actions.As a key member of this team, you will own and drive manufacturing risk management activities, including PFMEAs, process control plans, risk assessments, and implementation of mitigation strategies.Support internal and external audits, regulatory inspections, and interactions with regulatory agencies including FDA and notified bodies.Review and approve manufacturing quality documentation to ensure compliance with FDA QSR, ISO 13485, ISO 14971, ISO 5840, and applicable global regulations.Experience & Skills Needed:Education & ExperienceBachelor’s degree in Engineering, Physical Science, or related technical discipline.10+ years of Manufacturing Quality experience within the medical device industry, including significant Class III device experience.Minimum 5+ years supporting manufacturing process validation, risk management, nonconformance handling, CAPA, and process improvement activities in accordance with FDA QSR and ISO 13485 requirements.Experience supporting IDE products and clinical-stage manufacturing operations; as well as Class III implantable medical devices in a highly regulated environment.Direct experience supporting biological tissue processing or tissue-based medical device manufacturing, preferably involving pericardial tissue; as well as, tissue processing operations, sterilization methods, and manufacturing controls associated with implantable medical devices.Prior technical leadership, project leadership, or mentoring experience with demonstrated potential for future people leadership responsibilities.Deep understanding of manufacturing quality systems for Class III implantable medical devices; and, knowledge of FDA CFR 820, ISO 13485, ISO 14971, ISO 5840, and related global regulatory requirements.Preferred QualificationsMaster’s degree in Engineering or related discipline.Expertise with transcatheter heart valves (TAVR/TAVI), structural heart technologies, or other implantable cardiovascular devices.Experience supporting products through transition from clinical-stage development into commercialization. Experience working in rapidly scaling or pre-commercial organizations with evolving manufacturing and quality systems.Prior experience supporting FDA inspections, PMA activities, or commercialization readiness efforts for Class III implantable devices.Experience with biological pericardial tissue processing and tissue-based implant manufacturing; as well as support of sterilization validation and biological material characterization. ASQ certifications such as CQE, CQA, or Six Sigma certification.