Sr. Compliance Engineer, Safety

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 125,000 - 201,250; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Annual performance bonus

Vacation and sick time

Job summary

6267-Auris Health Inc. is seeking a Senior Compliance Engineer for their Robotics and Digital solutions group in Santa Clara, California. The role emphasizes safety engineering for surgical robotics, managing test teams, regulatory coordination, and documentation.

The ideal candidate will have over 5 years of hands-on safety testing experience and a Bachelor’s degree in Electrical Engineering. Benefits include competitive pay, medical, and retirement plans.

Qualifications

• Minimum 5+ years of hands-on safety testing experience.
• Experience in medical device product development and regulatory submissions.
• Strong technical-writing skills for producing compliance artifacts.

Responsibilities

• Develop risk-management documentation per ISO14971.
• Lead execution of safety verification per IEC60601-1.
• Coordinate safety design reviews with cross-functional teams.

Skills

Safety testing experience

Regulatory compliance evaluation

Technical writing skills

Interpersonal skills

Education

Bachelor’s degree in Electrical Engineering

Job description

Job Overview

Senior Compliance Engineer (Safety), 60601-1 Safety, for Johnson & Johnson MedTech’s Robotics and Digital solutions (RAD) group in Santa Clara, California. The role focuses on safety engineering for surgical robotics, managing test teams, documentation, and regulatory coordination.

Responsibilities

• Develop, review, and maintain risk‑management documentation per ISO14971, ensuring traceability from hazards to mitigations and test evidence.
• Lead execution of basic safety and electrical‑safety verification per IEC60601‑1 and associated particular & collateral standards.
• Perform basic safety tests, including dielectric‑strength/hi‑pot, leakage current, structural integrity, and other relevant checks.
• 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.

Required Qualifications

• 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 IEC60601‑1 (General), IEC60601‑2‑x, and IEC60601‑1‑x for medical electrical equipment.
• Hands‑on experience executing medical product safety testing under IEC60601‑1, IEC60601‑2‑18, IEC80601‑2‑77, IEC60601‑2‑2, with interpretation of test results and assessment of compliance.
• Ability to assess product designs for electrical, mechanical, and thermal safety, ensuring alignment with IEC requirements and supporting ISO14971 risk‑management activities.
• Strong technical‑writing skills for producing test plans, protocols, detailed test reports, and compliance artifacts suitable for audits and regulatory submissions.
• Excellent interpersonal skills for collaborating across engineering, quality, and regulatory teams.

Preferred Qualifications

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

Benefits and Compensation

Base pay range: $125,000.00 – $201,250.00 per year, with eligibility for an annual performance bonus. Additional compensation includes long‑term incentive programs and a consolidated retirement plan (401(k)).

Benefits include medical, dental, vision, life insurance, short‑term and long‑term disability, business accident insurance, and group legal insurance. Eligible employees may participate in the company‑sponsored retirement plan and long‑term incentive program.

Time‑off: Vacation up to 120hours per calendar year, sick time up to 40hours per calendar year, holiday pay (up to 13days per calendar year), and work, personal, and family time up to 40hours per calendar year.

Equity‑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 law. The company is committed to an inclusive interview process and provides accommodations for applicants with disabilities.