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.Accelerating the trajectory of health for humanity, Johnson & Johnson Robotics and Digital Solutions uses robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Founded in 2020, the group comprises three med‑tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions.Location: Santa Clara, California, United StatesSenior Compliance EngineerWe 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.Key ResponsibilitiesLead EMC and electrical safety compliance programs for medical products, ensuring conformity to IEC 60601-1, IEC 60601-1-2, and relevant collateral standards.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.) and communicate updates to internal stakeholders.Support regulatory submissions and audits by providing technical input and documentation evidence.Required QualificationsBachelor’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.Preferred QualificationsMaster’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.Core CompetenciesStrategic technical planning for regulatory complianceCross‑functional collaboration and communicationData‑driven problem‑solving and root‑cause analysisContinuous improvement mindsetStrong organizational and project management skillsIndependent execution of EMC and compliance activitiesCompensationThe anticipated pay range for this role is $115,000.00 to $197,800.00 USD annually. This position is eligible for an annual performance bonus and a long‑term incentive program.BenefitsMedical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance.401(k) retirement plan and savings plan.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.Required SkillsElectromagnetic Compatibility (EMC) Compliance, EMC Analysis, IEC 60601, ISO 14971 Risk Management, ISO StandardPreferred SkillsAccelerating, Coaching, Critical Thinking, Design Mindset, Feasibility Studies, Process Improvements, Product Design, Product Knowledge, Program Management, Prototyping, Research and Development, Robotic Automation, SAP Product Lifecycle Management, Smart Systems, Technical Research, Technical Writing, Technologically SavvyThis 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 https://www.careers.jnj.com 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 accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr