Role OverviewJoin the Robotics and Digital solutions (RAD) group at Johnson & Johnson to develop advanced robotic platforms for surgical surgery and healthcare. As a Senior Compliance Engineer (Safety), you will work closely with Hardware teams to develop designs that adhere to 60601-1 and its particular and collateral standards. This role offers significant technical responsibility, growth opportunities, and a significant impact on global healthcare.
What You Will Do
Develop, review, and maintain risk management documentation and responses per ISO 14971; 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.
Why It Might Be a Fit
This role requires a strong technical background in electrical engineering, experience with medical device product development and regulatory submissions, and excellent interpersonal skills collaborating across engineering, quality, and regulatory teams.
Requirements
- 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
- Hands-on experience executing medical product safety testing under IEC 60601-1
- Proven ability to assess product designs for electrical, mechanical, and thermal safety
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance
- Consolidated retirement plan (pension) and savings plan (401(k))
- Long-term incentive program
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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