Senior Quality Engineer, Medical Devices - Design Controls

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 125,000 - 210,000; Full time

Job summary

Intuitive Surgical, Inc. seeks a Quality Engineer to lead design controls and risk management for next‑generation surgical products. You will partner with cross‑functional teams to ensure product development meets regulatory standards and quality goals.

The role covers design verification/validation, risk assessment, and manufacturing transfer, with emphasis on reliability and process validation. Collaboration with suppliers and audits is expected.

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 of relevant experience and an Advanced Degree.
• Expertise in medical device standards such as ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, and FDA Design Controls. Previous experience risk-based V&V, process validation, limit/challenge testing is required
• Previous experience with reliability principles, testing, reliability growth planning, and execution is preferred
• Previous experience with running Verification & Validation Testing is preferred.
• Ability to navigate quality systems with minimal oversight on individual projects.
• Balanced risk decision-making to drive product quality, gain consensus, and work through technical challenges.
• Ability to solve complex problems with minimal oversight. Ability to articulate complex information to teams, including executive management.

Responsibilities

• Design Controls and Risk Management: contribute to planning and execution of design controls, risk management, and design verification/validation.
• Support the product design history file and ensure compliance with internal processes and external standards.
• Translate user needs into design while complying with usability and human factors standards.
• Define design inputs/outputs and traceability matrices with engineering.
• Contribute to risk-based design verification and validation.
• Assist in developing the product risk management file across user, design, process, and supplier aspects.
• Design Transfer: ensure reliable, scalable designs are transferred to manufacturing.
• Review design architectures, requirements and drawings early.
• Collaborate with manufacturing and supplier teams to transfer designs to production.
• Assist in supplier qualification and performance improvement.
• Support Design Reviews and Technical Reviews.
• Regulatory Support: assist regulatory with submissions and responses.
• Prepare for audits and interact with auditors.
• Process Improvement & Cross-Functional Collaboration: advance design controls and risk management processes.

Skills

Quality leadership

Design controls

Regulatory knowledge

Risk management

V&V

Problem solving

Education

Engineering degree (Electrical/Mechanical/CS/biomedical)

Advanced Degree (optional)

Job description

Intuitive Surgical, Inc. seeks a Quality Engineer to lead design controls and risk management for next‑generation surgical products. You will partner with cross‑functional teams to ensure product development meets regulatory standards and quality goals.

The role covers design verification/validation, risk assessment, and manufacturing transfer, with emphasis on reliability and process validation. Collaboration with suppliers and audits is expected.