Senior Medical Robotics Compliance Engineer

Johnson & Johnson Innovative Medicine; Santa Clara (CA); On-site; USD 125,000 - 201,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k)

Job summary

Johnson & Johnson is seeking a Senior Compliance Engineer (60601-1 Safety) in Santa Clara, CA, to drive safety testing and regulatory compliance for sophisticated robotic medical devices. You will collaborate with Hardware, Regulatory, and Quality teams to ensure adherence to IEC standards and ISO 14971 risk management.

The role offers significant technical responsibility, growth opportunities, and participation in global regulatory filings, with competitive benefits and a path toward leadership

Qualifications

• Bachelor’s degree in Electrical engineering (or equivalent).
• Minimum 5+ years of hands-on safety testing experience.

Responsibilities

• Develop, review, and maintain risk management documentation per ISO 14971; ensure traceability from hazards to mitigations and test evidence.
• Lead execution of basic safety and electrical safety verification per IEC 60601-1 and related standards.
• Perform basic safety tests including dielectric strength/hi pot, leakage current, structural integrity, etc.
• Coordinate cross-functional safety design reviews with Hardware, Regulatory, Quality, and Manufacturing teams to support product development and regulatory filings.
• Support external audits, supplier assessments, and interactions with notified bodies/regulatory agencies as needed.

Skills

Electrical safety testing

IEC 60601-1 awareness

Regulatory knowledge

Technical writing

Cross-functional collaboration

Audit support

Education

Bachelor’s degree in Electrical Engineering

Job description

Johnson & Johnson is seeking a Senior Compliance Engineer (60601-1 Safety) in Santa Clara, CA, to drive safety testing and regulatory compliance for sophisticated robotic medical devices. You will collaborate with Hardware, Regulatory, and Quality teams to ensure adherence to IEC standards and ISO 14971 risk management.

The role offers significant technical responsibility, growth opportunities, and participation in global regulatory filings, with competitive benefits and a path toward leadership