Senior Quality Engineer - MedTech, Design Controls Lead

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

Benefits offered by this job

Equal Opportunity Employer

Job summary

Intuitive Surgical in Sunnyvale seeks a Senior Quality Engineer 4 to lead design controls, risk management, and regulatory compliance for next‑gen robotic systems. You will guide cross‑functional teams through verification, validation, and design transfer while ensuring manufacturing readiness and high quality standards.

The role requires deep knowledge of ISO 14971, IEC 60601, and FDA Design Controls, with strong leadership to drive product quality and regulatory success.

Qualifications

• Minimum of 8 years of related experience with a University Degree or 5 years with an Advanced Degree.
• Expertise in medical device standards and risk-based V&V, process validation, limit/challenge testing.
• Experience with reliability principles and design verification/validation.

Responsibilities

• Contribute to design controls, risk management, and design verification/validation for new products.
• Support development of design history file and ensure regulatory compliance.
• Collaborate with engineering and manufacturing for design transfer and production readiness.
• Provide regulatory support including submissions and audits.

Skills

Quality engineering

Regulatory understanding

Risk management

Design controls

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Tools

ISO 14971

IEC 60601

IEC 62304

ISO 80002-1

FDA Design Controls

Job description

Intuitive Surgical in Sunnyvale seeks a Senior Quality Engineer 4 to lead design controls, risk management, and regulatory compliance for next‑gen robotic systems. You will guide cross‑functional teams through verification, validation, and design transfer while ensuring manufacturing readiness and high quality standards.

The role requires deep knowledge of ISO 14971, IEC 60601, and FDA Design Controls, with strong leadership to drive product quality and regulatory success.