Johnson & Johnson MedTech · 8 hours ago
Senior Compliance Engineer
Santa Clara, CA
Full-time
Onsite
Senior Level
$115K/yr - $198K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to enhancing health through advanced technologies. The Senior Compliance Engineer will ensure that medical devices meet EMC and product safety standards, guiding product development teams and coordinating compliance activities for timely market access.
Hospital & Health Care
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
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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