Sr. Compliance Engineer, Safety

Johnson & Johnson MedTech; Santa Clara (CA); On-site; USD 125,000 - 201,250; Full time

Benefits offered by this job

Annual performance bonus

Medical, dental, vision insurance

401(k) retirement plan

Vacation up to 120 hours per year

Job summary

Johnson & Johnson MedTech is seeking a Senior Compliance Engineer focusing on safety compliance for advanced robotic systems in Santa Clara, California. You will ensure adherence to IEC 60601-1 safety standards and play a crucial role in developing world-class medical devices.

This position requires collaboration with hardware teams and offers opportunities for significant professional growth as part of a dedicated engineering team aiming to improve patient care.

Qualifications

• Minimum 5+ years of hands-on safety testing experience.
• Experience evaluating product safety and regulatory compliance against IEC 60601-1 and applicable standards.
• Strong technical writing skills for test plans and compliance artifacts.

Responsibilities

• Develop and maintain risk management documentation per ISO 14971.
• Lead execution of safety verification per IEC 60601-1.
• Coordinate safety design reviews with cross-functional teams.

Skills

IEC Standards

Medical Device Compliance

Product Safety Standards

Safety Compliance

Technical Writing Documentation

Education

Bachelor's degree in Electrical Engineering or equivalent

Job description

Job Function

R&D Product Development

Job Sub Function

R&D Electrical/Mechatronic Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Santa Clara, California, United States of America

Job Description

The Robotics and Digital solutions (RAD) group, part of the Johnson & Johnson family of companies, is recruiting for a Sr. Compliance Engineer (Safety).

What We Do

At Johnson & Johnson MedTech, we are building the future of robotic surgery and healthcare through innovation and technical excellence. Our goal is to develop advanced robotic platforms that are precise, reliable, and accessible. Our team focuses on creating solutions that empower surgeons and improve patient outcomes worldwide.

Who We Are

Within RAD R&D we are a team of clinical, electrical, firmware, mechanical, mechatronics, robotic controls, systems and software engineers who are passionate about improving patient care. The team includes a wide range of experience levels from junior engineers to industry experts. We follow an iterative, collaborative approach to product development, working across clinical, instrument, accessories, and system teams. We prioritize autonomy, foster a culture of learning, and value diversity of thought and background.

You

As a Senior Compliance Engineer (60601-1 Safety), you will join our journey to develop and deliver some of the most sophisticated medical robotic systems in the world. You will work closely with our Hardware teams to develop designs going through the hardware development process that adheres to 60601-1 and its particular and collateral standards applicable to a surgical robot. This role offers significant technical responsibility, growth opportunities, and the chance to have a significant impact on global healthcare.

Performance Objectives And Responsibilities

• Develop, review, and maintain risk management documentation and responses per ISO 14971; ensure traceability from hazards to mitigations and test evidence.
• Lead execution of basic safety and electrical safety verification per IEC 60601-1 and associated particular and collateral standards.
• Perform basic safety tests including dielectric strength/hi pot, leakage current, structural integrity, etc.
• Coordinate cross‑functional safety design reviews with Hardware, Regulatory, Quality, and Manufacturing teams to support product development and regulatory filings.
• Support external audits, supplier assessments, and interactions with notified bodies and regulatory agencies as needed.

Qualifications

Required Knowledge, Skills, Education, and Experience

• Bachelor's degree in Electrical engineering (or equivalent). Minimum 5+ years of hands‑on safety testing experience.
• Experience evaluating product safety and regulatory compliance against IEC 60601-1 and applicable 60601‑2‑x and 60601‑1‑x standards.
• Hands‑on experience executing medical product safety testing under IEC 60601‑1, IEC 60601‑2‑18, IEC 80601‑2‑77 and IEC 60601‑2‑2, including interpretation of test results and assessment of compliance.
• Proven ability to assess product designs for electrical, mechanical, and thermal safety, ensuring alignment with IEC requirements and supporting risk management activities per ISO 14971.
• Strong technical writing skills and experience producing test plans, protocols, detailed test reports, and compliance artifacts suitable for audits and regulatory submissions.
• Excellent interpersonal skills collaborating across engineering, quality, and regulatory teams.

Preferred Knowledge, Skills, Education, and Experience

• Experience in medical device product development and regulatory submissions.
• Experience with medical devices comprised of complex capital equipment.
• Proven hands‑on experience performing basic electrical safety tests: hi pot/dielectric strength, earth/continuity, patient/earth/touch leakage current, and mechanical structural integrity.

Compensation & Benefits

The anticipated base pay range for this position is $125,000.00 to $201,250.00.

The Company maintains highly competitive, performance‑based compensation programs. This position is eligible for an annual performance bonus in accordance with the applicable plan, and for the Company’s long‑term incentive program.

Employees and/or eligible dependents may be eligible to participate in Company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Employees may also participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time‑off benefits: vacation up to 120 hours per calendar year; sick time up to 40 hours; holiday pay, including floating holidays, up to 13 days; work, personal, and family time up to 40 hours.

Required Skills

• IEC Standards
• Medical Device Compliance
• Product Safety Standards
• Safety Compliance
• Technical Writing Documentation

Preferred Skills

• Accelerating
• Coaching
• Critical Thinking
• Design Mindset
• Feasibility Studies
• Process Improvements
• Product Design
• Product Knowledge
• Program Management
• PrototypingResearch and Development
• Robotic Automation
• SAP Product Lifecycle Management
• Smart Systems
• Technical Research
• Technical Writing
• Technologically Savvy

Equal Opportunity Employer

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.

Inclusive Hiring

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.