Senior Safety Engineer - Medical Robotics

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

Benefits offered by this job

Annual bonus

Health benefits

Retirement plan

Job summary

Johnson & Johnson MedTech RAD group is recruiting a Sr. Compliance Engineer (Safety) to develop and deliver sophisticated medical robotic systems, working with Hardware teams to ensure safety compliance across IEC standards and ISO 14971 risk management.

This role offers growth, cross-functional collaboration with Regulatory, Quality, and Manufacturing, and opportunities to contribute to regulatory filings and audits.

Qualifications

• Bachelor's degree in Electrical engineering (or equivalent).
• Minimum 5+ years of hands-on safety testing experience.
• Experience evaluating product safety and regulatory compliance against IEC 60601-1 and related standards.
• Hands-on experience with medical safety testing under IEC 60601-1 and related standards.
• Ability to assess electrical, mechanical, and thermal safety and support ISO 14971 risk management.

Responsibilities

• Develop, review, and maintain risk management documentation and responses per ISO 14971.
• Lead safety verification per IEC 60601-1 and related standards.
• Perform basic safety tests (dielectric strength, leakage, etc.).
• Coordinate cross-functional safety design reviews for regulatory filings.
• Support audits and regulatory interactions as needed.

Skills

Safety testing

Regulatory compliance

Technical writing

Cross-functional collaboration

Risk management

Education

Bachelor's degree in Electrical engineering

Tools

IEC 60601-1

IEC 60601-2-18

IEC 80601-2-77

IEC 60601-2-2

ISO 14971

Job description

Johnson & Johnson MedTech RAD group is recruiting a Sr. Compliance Engineer (Safety) to develop and deliver sophisticated medical robotic systems, working with Hardware teams to ensure safety compliance across IEC standards and ISO 14971 risk management.

This role offers growth, cross-functional collaboration with Regulatory, Quality, and Manufacturing, and opportunities to contribute to regulatory filings and audits.