Sr. Compliance Engineer, Safety

Johnson Johnson; California; Vor Ort; USD 125.000 - 201.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision benefits

401(k) retirement plan

Paid time off

Zusammenfassung

Johnson & Johnson MedTech RAD R&D is recruiting a Sr. Compliance Engineer (Safety) in Santa Clara, CA, to lead safety validation for robotic medical devices. You will collaborate across hardware, regulatory, and quality teams to ensure 60601-1 compliance and robust risk management throughout development.

The role emphasizes hands‑on safety testing, technical writing, and audits support, with opportunities to influence global regulatory submissions and product safety programs.

Qualifikationen

• 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 (General Standard), including applicable particular (60601-2-x) and collateral standards (60601-1-x) for medical electrical equipment.
• 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 against standard requirements.
• Proven ability to assess product designs for electrical, mechanical, and thermal safety, ensuring alignment with applicable IEC requirements and supporting risk management activities in accordance with ISO 14971.
• Strong technical writing skills and experience producing test plans and protocols, detailed test reports, and compliance artifacts suitable for audits and regulatory submissions.
• Excellent interpersonal skills collaborating across engineering, quality, and regulatory teams.

Aufgaben

• 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/regulatory agencies as needed.

Kenntnisse

IEC Standards

Medical Device Compliance

Safety Testing

Technical Writing

Cross-functional Collaboration

Regulatory Submissions

Ausbildung

Bachelor’s degree in Electrical Engineering

Tools

SAP Product Lifecycle Management

Jobbeschreibung

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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. Our environment is inclusive, supportive, and driven by a shared commitment to innovation and excellence in healthcare.

You:

As a Senior Compliance Engineer (60601-1 Safety), on our team, 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/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.

• Demonstrated experience evaluating product safety and regulatory compliance against IEC 60601-1 (General Standard), including applicable particular (60601-2-x) and collateral standards (60601-1-x) for medical electrical equipment.

• 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 against standard requirements.

• Proven ability to assess product designs for electrical, mechanical, and thermal safety, ensuring alignment with applicable IEC requirements and supporting risk management activities in accordance with ISO 14971.

• Strong technical writing skills and experience producing test plans and 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.

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. 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.

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: https://www.careers.jnj.com/employee-benefits

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.

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, Prototyping, Research and Development, Robotic Automation, SAP Product Lifecycle Management, Smart Systems, Technical Research, Technical Writing, Technologically Savvy

The anticipated base pay range for this position is :

$125,000.00 - $201,250.00

Additional Description for Pay Transparency: