Senior Quality Engineer — Medical Devices (Design Controls)

Intuitive; Sunnyvale (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA seeks a strong quality functional leader to support the development of next generation surgical systems. The role provides expertise in design controls, risk management, process validation, and reliability-focused design for manufacturing.

You will participate in cross-functional product development teams to ensure compliance with internal quality processes and external regulatory requirements, and collaborate across engineering, manufacturing, and supplier

Qualifications

• Design Controls and Risk Management: Contribute to the planning and execution of design controls, risk management, and design verification/validation for new products.
• Regulatory Support: Support Regulatory Affairs with creating submissions and responding to submission questions.
• Process Improvement & Cross-Functional Collaboration: Support continuous improvement in design control & risk management quality processes and methodologies.

Responsibilities

• Design Controls and Risk Management for new products including design history file alignment and traceability.
• Design transfer activities with manufacturing and supplier teams to enable scalable production.
• Regulatory support including submissions and audits.

Job description

Intuitive Surgical in Sunnyvale, CA seeks a strong quality functional leader to support the development of next generation surgical systems. The role provides expertise in design controls, risk management, process validation, and reliability-focused design for manufacturing.

You will participate in cross-functional product development teams to ensure compliance with internal quality processes and external regulatory requirements, and collaborate across engineering, manufacturing, and supplier