Sr. Compliance and Safety Engineer | Medical Device (HE2026)

Job Description

Job Description

Job Title: Sr. Compliance Engineer, Safety
Location (On-site, Remote, or Hybrid?): Santa Clara, CA (hybrid)
Contract Duration: PERM

Job Description:
The Robotics and Digital solutions (RAD) group, is recruiting for a Sr. Compliance Engineer (Safety).

What We Do:
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.

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.