Senior Medical Robotics Safety & Compliance Engineer

Biopharma Careers; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Job summary

Johnson & Johnson is recruiting a Senior Compliance Engineer (60601-1 Safety) in Santa Clara, CA to join the RAD team developing advanced robotic medical systems.

You will assess electrical, mechanical, and thermal risks, lead safety testing and regulatory compliance activities, and collaborate across Hardware, Regulatory, and Quality functions to enable robust medical device development and successful filings.

Qualifications

• Bachelor's degree in Electrical engineering (or equivalent).
• 5+ years of hands-on safety testing experience.
• Experience evaluating product safety against IEC 60601-1 and related standards.
• Experience performing medical device safety tests under IEC 60601-1/-2-18, -2-77, -2-2.

Responsibilities

• Develop, review, and maintain risk management documentation per ISO 14971.
• Lead safety verification per IEC 60601-1 and related standards.
• Perform basic safety tests (dielectric strength, hi-pot, leakage, etc.).
• Coordinate cross-functional safety design reviews with Hardware, Regulatory, Quality, and Manufacturing.
• Support external audits and regulatory submissions.

Skills

Electrical engineering

Safety testing

IEC 60601-1

ISO 14971 risk mgmt

Test plan writing

Cross-functional collaboration

Education

Bachelor's degree in Electrical engineering (or equivalent)

Job description

Johnson & Johnson is recruiting a Senior Compliance Engineer (60601-1 Safety) in Santa Clara, CA to join the RAD team developing advanced robotic medical systems.

You will assess electrical, mechanical, and thermal risks, lead safety testing and regulatory compliance activities, and collaborate across Hardware, Regulatory, and Quality functions to enable robust medical device development and successful filings.