Senior Quality Engineer - MedTech (Electro‑Mechanical)

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 128,000 - 216,000; Full time

Job summary

Intuitive Surgical, Inc. in Sunnyvale, CA, seeks a Senior Quality Engineer to guide product development from concept to commercialization. You will own design controls, risk management, and SDLC, ensuring products meet internal quality processes and external regulations.

You will partner with engineering, manufacturing, regulatory, and supplier teams to drive verification, validation, and design transfers, while supporting audits and regulatory submissions.

Qualifications

• 8+ years in Quality Engineering, 4+ years in electromechanical systems or software.
• Strong design controls and risk management from concept to launch.
• Experience with ISO 13485, ISO 14971, FDA QSR.
• Navigate quality systems with minimal oversight.
• Balanced risk-based decisions to ensure product quality.
• Able to articulate complex information to executives.

Responsibilities

• Plan and execute design controls and risk management.
• Support design verification and validation.
• Collaborate with cross-functional teams for transfer to manufacturing.
• Assist supplier qualification and audits.
• Support regulatory submissions and audits.
• Lead design reviews and technical reviews.

Skills

Design controls

Risk management

SDLC

Reliability engineering

FDA/ISO knowledge

Executive communication

Education

Bachelor's degree in STEM

Job description

Intuitive Surgical, Inc. in Sunnyvale, CA, seeks a Senior Quality Engineer to guide product development from concept to commercialization. You will own design controls, risk management, and SDLC, ensuring products meet internal quality processes and external regulations.

You will partner with engineering, manufacturing, regulatory, and supplier teams to drive verification, validation, and design transfers, while supporting audits and regulatory submissions.