We're looking for a highly qualified Senior Design Assurance Engineer (sustaining) to join our San Diego team. Your role: Provide quality engineering support and leadership for products which includes launch and stabilization through concept, design, and development as well as representing and providing quality engineering support on commercially launched products through sustaining initiatives (design, supplier, obsolescence changes). Lead and support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in support of product design changes. Participate in design reviews to ensure all pre-defined requirements have been met. Lead the risk management process and on-going maintenance of the risk management file (Risk Management Plan, FMEAs, Hazard Analysis, Risk Management Report). Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation as necessary. Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriate preventive/corrective actions. Monitoring/trending product issues/complaints and initiating appropriate quality planning principles to resolve such issues. Ability to use quality tools for effective problem solving (5 Why, Pareto, Fish bone, FMEA). Maintain knowledge of current regulatory requirements, applicable laws and standards as well as internal quality system requirements. Represent Philips as appropriate in FDA, notified body, internal and external audits. Mentoring of junior staff including training, motivating and monitoring.