Role summary
The Robotics and Digital solutions (RAD) group, part of the organization & the organization family of companies, is recruiting for a Sr. Compliance Engineer (Safety).
At the organization, 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.
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.
Requirements
- 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.
IEC Standards, Medical Device Compliance, Product Safety Standards, Safety Compliance, Technical Writing Documentation
Nice to have
- 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.
This position is eligible to participate in the Company’s long-term incentive program.
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
Standards
- ISO 14971
- IEC 60601