Senior Compliance Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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R&D Product Development

R&D Electrical/Mechatronic Engineering

Scientific/Technology

Santa Clara, California, United States of America

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Compliance Engineer located in Santa Clara, CA.

At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms:
Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes.

We are seeking a Senior Compliance Engineer who will be responsible for ensuring that all electrical and electronic medical devices meet applicable EMC and product safety standards in accordance with the IEC 60601 series. The role involves guiding product development teams through compliance requirements, coordinating global test and certification activities, and ensuring timely market access for medical electrical equipment. This position requires strong technical expertise, cross-functional collaboration, collaboration with third‑party consultants and agencies, and the ability to navigate complex regulatory frameworks across multiple regions.

• Lead EMC and electrical safety compliance programs for medical products, ensuring conformity to:
  • IEC 60601-1 (General safety and essential performance)
  • IEC 60601-1-2 (EMC requirements)
  • Relevant collateral (IEC 60601-1-x) and particular (IEC 60601-2-x, IEC 80601-2-x) standards
  • Regional adaptations (EN/UL/CE/CSA 60601 series)
• Partner with R&D, Systems, and Quality teams to define design‑for‑compliance strategies early in the product lifecycle.
• Develop and maintain EMC and safety test plans
  , including pre‑compliance and final certification testing.
• Conduct or oversee pre‑compliance evaluations
  , troubleshoot failures, and recommend EMC mitigation and safety design improvements
  .
• Serve as the primary technical contact for Notified Bodies, NRTLs, and accredited test laboratories (TÜV, UL, Intertek, BSI etc.).
• Manage certification schedules
  , quotes, and deliverables for assigned products.
• Review and approve schematics, PCB layouts, enclosure designs, and grounding/shielding strategies for compliance.
• Ensure complete and accurate technical documentation (test reports, risk analyses, Declarations of Conformity, etc.) is maintained in compliance with ISO 13485 and ISO 14971 processes.
• Stay current with global regulatory changes (EU MDR, FDA, China NMPA, etc.) impacting EMC and safety compliance and communicate updates to internal stakeholders.
• Support regulatory submissions and audits by providing technical input and documentation evidence.

• Bachelor's degree in Electrical Engineering, Electronics, or a related discipline.
• 5+ years of experience in EMC and electrical safety compliance engineering, preferably within the medical device or high‑reliability electronics industry
  .
• Proven expertise in the IEC 60601 family of standards and relevant EMC standards (CISPR 11 / EN 55011, IEC 61000 series).
• Hands‑on…