Senior Quality Engineer - MedTech (Onsite, Impactful Work)

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

Job summary

Intuitive Surgical is seeking a Senior Quality Engineer to guide design control, risk management, and the software/hardware lifecycle from concept through commercialization. You will ensure adherence to quality processes and support cross-functional teams to deliver safe, reliable devices.

The role emphasizes compliance with ISO 13485, ISO 14971 and FDA Standards, audits, and regulatory submissions, while advancing scalable, high-quality medical systems for patients worldwide.

Qualifications

• 8+ years in Quality Engineering with 4+ years in electromechanical systems or software design.
• Strong design control and risk management from concept to launch.
• Experience with ISO 13485, ISO 14971 and FDA QSR compliance.

Responsibilities

• Lead design controls and risk management across product development.
• Support regulatory submissions and audits with engineering evidence.
• Collaborate with manufacturing, supplier, and test teams to ensure scalable designs.

Skills

Quality Engineering

Electromechanical

Software Design

Regulatory Knowledge

Education

Bachelor's degree in STEM

Job description

Intuitive Surgical is seeking a Senior Quality Engineer to guide design control, risk management, and the software/hardware lifecycle from concept through commercialization. You will ensure adherence to quality processes and support cross-functional teams to deliver safe, reliable devices.

The role emphasizes compliance with ISO 13485, ISO 14971 and FDA Standards, audits, and regulatory submissions, while advancing scalable, high-quality medical systems for patients worldwide.