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

📌 Design Quality Engineer At Capgemini Burlington
🏢 Capgemini
📍 Burlington