Senior Compliance Engineer, Safety

About the role

Johnson & Johnson MedTech is building advanced robotic surgery platforms. As a Senior Compliance Engineer (Safety) you will ensure that hardware designs meet IEC 60601‑1 and related standards, supporting regulatory submissions and global patient safety.

Key responsibilities

• Develop, review, and maintain risk management documentation per ISO 14971, ensuring traceability from hazards to mitigations.
• Lead basic safety and electrical safety verification activities according to IEC 60601‑1 and its particular and collateral standards.
• Perform safety tests such as dielectric strength, leakage current, and structural integrity, and document results.
• Coordinate cross‑functional safety design reviews with hardware, regulatory, quality, and manufacturing teams.
• Support external audits, supplier assessments, and interactions with notified bodies.

Required profile

• Bachelor’s degree in Electrical Engineering or equivalent.
• Minimum 5 + years of hands‑on safety testing experience on medical devices.
• Demonstrated experience with IEC 60601‑1, IEC 60601‑2‑18, IEC 80601‑2‑77, and IEC 60601‑2‑2 compliance.
• Strong technical writing skills for test plans, protocols, and regulatory artifacts.
• Excellent interpersonal skills for collaboration across engineering, quality, and regulatory functions.

Required skills

• IEC 60601‑1 (General and particular/collateral standards)
• ISO 14971 risk management
• Electrical safety testing (hi‑pot, leakage current, dielectric strength)
• Technical documentation and test reporting

What we offer

• Base salary range $125,000 – $201,250 per year.
• Annual performance bonus and long‑term incentive program.
• Comprehensive benefits including medical, dental, vision, life insurance, disability, 401(k), and paid time off.
• Inclusive, supportive work environment focused on innovation in healthcare.