Senior Compliance Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 were 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. Youll 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.

Key Responsibilities:

• Lead EMC and electrical safety compliance programs for medical products ensuring conformity to:

• • IEC 60601-1 (General safety and essential performance)

  • IEC (EMC requirements)

  • Relevant collateral (IECx) and particular (IECx IECx) 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.

Required Qualifications:

• Bachelors 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.

Preferred Qualifications:

• Masters 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:2014/2020) and cybersecurity implications for connected medical devices.

• Working knowledge of FDA 510(k) and EU MDR Technical File processes.

Core Competencies:

• Strategic technical planning for regulatory compliance

• Cross-functional collaboration and communication

• Data-driven problem-solving and root cause analysis

• Continuous improvement mindset

• Strong organizational and project management skills

• Independent execution of EMC and compliance activities

The anticipated pay range for this role is $115000.00 to $197800.00 USD Annual

The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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

For additional general information on Company benefits please go to: job posting is anticipated to close on 11/24/25. The Company may however extend this time-period in which case the posting will remain available on to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodationexternal applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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