Senior Medical Device Safety & Compliance Engineer

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

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.