Senior Quality Engineer - Future Forward / NPD
On-site · Sunnyvale, California, United States
Job Summary
Senior Quality Engineer to lead design controls, risk management, and design verification/validation for next-generation robotic-assisted surgical systems. Responsible for ensuring product development meets regulatory requirements, developing and maintaining design history files, and collaborating across cross-functional teams to transfer scalable designs to manufacturing. Roles include supporting regulatory submissions and audits, improving quality processes, and driving risk-based design decision-making for high-complexity medical devices. The role emphasizes quality systems, validation, supplier collaboration, and continuous improvement in a fast-paced healthcare technology environment.
Required Qualifications
- University degree in Electrical Engineering, Mechanical Engineering, Computer Science, Software Engineering, Biomedical Engineering or equivalent.
- 6+ years of related experience with an advanced degree or 8+ years with a university degree.
- Strong proficiency with FDA Design Controls and international standards (ISO 13485, ISO 14971, IEC 60601/62304).
- Experience with risk-based Verification & Validation (V&V), process validation, and reliability testing.
- Experience with robotic or complex electromechanical devices preferred.
- Ability to navigate quality systems with minimal oversight; proven problem-solving and communication skills.
- Preferred certifications: ASQ CQE, ASQ CRE, or Six Sigma Black Belt.
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