Medical Device Safety and Compliance Engineer SC2026

Techlink Systems; Santa Clara (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Techlink Systems seeks a Sr. Compliance Engineer (Safety) in Santa Clara, CA, hybrid on-site. The role focuses on developing and delivering safety compliance for advanced robotic medical systems under IEC 60601-1 and related standards.

You will collaborate with Hardware, Regulatory, Quality, and Manufacturing teams to support product development and regulatory filings, performing risk management and safety verification with strong documentation and test evidence.

Qualifications

• 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 related standards.
• Hands-on experience with IEC 60601-1, IEC 60601-2-18, IEC 80601-2-77, IEC 60601-2-2.
• Ability to assess electrical, mechanical, and thermal safety in designs.

Responsibilities

• Develop, review, and maintain risk management documentation per ISO 14971 with traceability from hazards to mitigations and test evidence.
• Lead basic safety and electrical safety verification per IEC 60601-1 and related standards.
• Perform basic safety tests (dielectric strength, hi-pot, leakage current, structural integrity).
• Coordinate cross-functional safety design reviews with Hardware, Regulatory, Quality, and Manufacturing teams.
• Support external audits, supplier assessments, and interactions with regulatory bodies as needed.

Skills

Safety testing

Regulatory compliance

Technical writing

Cross-functional collaboration

IEC 60601-1 knowledge

Education

Bachelor's degree in Electrical engineering

Job description

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.