Senior Compliance Engineer

Johnson & Johnson • Santa Clara, CA

5d

About The Position

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 MedTech, 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. Learn more at https://www.jnj.com 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.

Requirements

• 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 experience with EMC test equipment and familiarity with immunity and emissions testing methods.
• Experience interfacing with regulatory bodies and external test labs for product certifications.
• Proven expertise in diagnosing and resolving EMC and Safety issues by performing root cause analysis, and hands-on-testing.
• Experience offering full lifecycle support for EMC and Safety from product concept to certification and production.
• Working knowledge of risk management (ISO 14971), quality systems (ISO 13485), and design control processes.
• Demonstrated success in managing global product compliance programs across multiple regulatory regions.
• Strong analytical, documentation, and communication skills, with the ability to translate complex regulatory requirements into clear engineering guidance.
• Electromagnetic Compatibility (EMC) Compliance
• EMC Analysis
• IEC 60601
• ISO 14971 Risk Management
• ISO Standard

Nice To Haves

• Master’s degree (or higher) in Electrical Engineering, Electronics, or a related discipline.
• Certification such as iNARTE EMC Engineer, Certified Product Safety Engineer, or equivalent.
• Familiarity with wireless coexistence standards (IEC 60601-1-2:2014/2020) and cybersecurity implications for connected medical devices.
• Working knowledge of FDA 510(k) and EU MDR Technical File processes.
• 510 (K)
• Cybersecurity Compliance
• FDA Compliance
• FDA Submissions
• Product Safety Engineering

Responsibilities

• 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.

Benefits

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits: 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees