Staff Electrical Compliance Engineer - R&D Robotics

Role Summary

Staff Electrical Compliance Engineer located in Santa Clara, CA, focusing on IEC 60601 device compliance, EMC testing, and Regulatory submissions within Johnson & Johnson’s Robotics and Digital Solutions group.

Responsibilities

• Define IEC-60601 executional strategy across geographies and commercial releases.
• Support onsite EMC testing in RF pre-compliance lab and external EMC testing at compliance laboratories for the robotic system.
• Develop test and verification methods for electromagnetic compatibility across platforms.
• Negotiate test strategy and execution with NRTLs in support of program objectives.
• Advise design engineering on EMC guidelines and perform design reviews across the robotic platform.
• Support EMC troubleshooting and iterative EMC design improvements.
• Generate isolation diagrams, risk documentation, reports, and 60601-related documentation.
• Support regulatory submissions across geographies and clinical indications.

Qualifications

• Bachelors in Electrical Engineering (or related field) with 8+ years, or Advanced Degree with 6+ years of industry experience.
• Solid understanding of IEC 60601-1-2, FCC CFR Title 47 Part 15 Subparts A‚ÄìC, RAD (2014/53/EU), and Japan MIC Radio Laws.
• Experience with fielded medical device products and negotiating with NRTLs.
• Knowledge of tools and procedures for evaluating and testing EMC compliance.
• Experience with Quality risk management processes for medical devices (ISO 14971).
• Proven technical direction, mentorship, and project leadership including external contractors.

Skills

• Electronics design experience in safety-critical applications (preferred).
• Experience with complex capital medical devices.
• Signal integrity and RF design knowledge.
• Programming experience in Python, Linux, or similar.
• Experience with Altium Designer.