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 innovative medical devices with Capgemini Engineering.
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