Senior Quality Engineer - Medical Devices, Design Controls

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 150,000 - 184,000; Full time

Job summary

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer 4 to lead design controls, risk management, and regulatory support for next‑generation devices like the da Vinci system. This role drives reliability, design transfer to manufacturing, and audits with minimal supervision.

Ideal candidates have extensive experience with ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, FDA Design Controls, and risk-based V&V, plus strong problem-solving skills and

Qualifications

• Minimum of 8 years of related experience with a University Degree in Electrical Engineering, Mechanical Engineering, Computer Science, software engineering, biomedical engineering, or 5 years with an Advanced Degree.
• Expertise in medical device standards ISO 14971, IEC 60601, IEC 62304, ISO 80002-1 and FDA Design Controls; experience with risk-based V&V, process validation, and limit/challenge testing.

Responsibilities

• Design Controls and Risk Management: contribute to planning and execution of design controls, risk management, and design verification/validation.
• Design Transfer: ensure reliable and scalable designs are transferred to manufacturing and collaborate with cross-functional teams to facilitate production transfer.
• Regulatory Support: support regulatory submissions and audits with preparation and interaction with auditors.
• Process Improvement & Cross-Functional Collaboration: support continuous improvement of design control and risk management processes.

Skills

ISO 14971

IEC 60601

IEC 62304

ISO 80002-1

FDA Design Controls

Risk-based V&V

Process Validation

Reliability Testing

Executive-level communication

Problem Solving

Education

University Degree in Engineering

Job description

Intuitive Surgical, a global leader in robotic-assisted surgery, seeks a Senior Quality Engineer 4 to lead design controls, risk management, and regulatory support for next‑generation devices like the da Vinci system. This role drives reliability, design transfer to manufacturing, and audits with minimal supervision.

Ideal candidates have extensive experience with ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, FDA Design Controls, and risk-based V&V, plus strong problem-solving skills and