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Senior Compliance Engineer

California Jobs, Santa Clara, California, us, 95053

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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

Job Function R&D Product Development

Job Sub Function R&D Electrical/Mechatronic Engineering

Job Category Scientific/Technology

Job Posting Locations Santa Clara, California, United States of America

Job Description 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.

Key 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

(TÃV, 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

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.

Preferred Qualifications

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.

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

Pay Range The anticipated pay range for this role is $115,000.00 to $197,800.00 USD Annual.

Benefit Overview 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 corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s 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 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.

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:

This 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 to accept additional applications.

Equal Opportunity Statement 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 . internal employees contact AskGS to be directed to your accommodation resource.

Required Skills Electromagnetic Compatibility (EMC) Compliance, EMC Analysis, IEC 60601, ISO 14971 Risk Management, ISO Standard.

Preferred Skills

Accelerating

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 Savvy

Pay Transparency Notice The anticipated base pay range for this position is $115,000.00 to $197,800.00.

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