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
- Strong analytical skills and effective communication abilities Become a key player in ensuring the reliability and safety of cutting-edge medical devices with Capgemini Engineering.