Elevate the quality of medical devices with Capgemini Engineering as a Senior Design Quality Engineer. Drive compliance and excellence in product development for Class II/III medical devices in a hybrid work model.
Capgemini Engineering seeks an experienced Senior Design Quality Engineer, focusing on medical device development. Your role involves ensuring end-to-end design quality, leading risk management, and overseeing software SDLC compliance. You'll work with cross-functional teams to align design controls with regulatory standards and support key product lifecycle phases.
Key Responsibilities: • Ensure compliance with design controls throughout product lifecycles • Maintain complete traceability from design inputs to verification • Lead risk management activities,
including FMEA and hazard analysis • Oversee software verification and validation per regulatory standards • Support audits, regulatory submissions, and continuous improvement initiatives
Requirements: • Bachelor’s degree in Engineering or related field • 10+ years in software quality assurance in regulated environments • Familiarity with FDA regulations and standards • Experience in design and risk management for medical devices • Robust analytical skills and effective communication abilities
Become a key player in ensuring the reliability and safety of innovative medical devices with Capgemini Engineering. #J-18808-Ljbffr