Sr. Compliance Engineer, Safety

About the role

The Robotics and Digital solutions (RAD) group, part of the Johnson & Johnson family of companies, is recruiting for a Sr. Compliance Engineer (Safety).

Responsibilities

• Develop, review, and maintain risk management documentation and responses 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 associated particular and collateral standards.
• Perform basic safety tests including dielectric strength/hi pot, leakage current, structural integrity, etc.
• Cook up 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.

Qualifications

• Bachelor's degree in Electrical engineering (or equivalent).
• Minimum 5+ years of hands‑on safety testing experience.
• Demonstrated experience evaluating product safety and regulatory compliance against IEC 60601-1 (General Standard), including applicable particular (60601-2-x) and collateral standards (60601-1-x) for medical electrical equipment.
• Hands-on experience executing medical product safety testing under IEC 60601-1, IEC 60601-2-18, IEC 80601-2-77 and IEC 60601-2-2, including interpretation of test results and assessment of compliance against standard requirements.
• Proven ability to assess product designs for electrical, mechanical, and thermal safety, ensuring alignment with applicable IEC requirements and supporting risk management activities in accordance with ISO 14971.
• Strong technical writing skills and experience producing test plans and protocols, detailed test reports, and compliance artifacts suitable for audits and regulatory submissions.
• Excellent interpersonal skills collaborating across engineering, quality, and regulatory teams.

Preferred Qualifications

• Experience in medical device product development and regulatory submissions.
• Experience with medical devices comprised of complex capital equipment.
• Proven hands‑on experience performing basic electrical safety tests: hi pot/dielectric strength, earth/continuity, patient/earth/touch leakage current, and mechanical structural integrity.

Pay

The anticipated base pay range for this position is $125,000.00 to $201,250.00.