Senior Compliance Engineer

Job Summary

The Senior Compliance Engineer is responsible for ensuring that all products and subsystems meet global regulatory, safety, and compliance requirements throughout the product lifecycle. This role partners cross‑functionally with Engineering, Quality, Regulatory Affairs, and Manufacturing to proactively design for compliance, manage certification activities, and sustain approvals in a highly regulated medical device environment. Reports to the Director of Systems Engineering in the Systems Engineering & Applied Science department.

• Maintain product compliance with global regulatory and safety standards, including CE Mark and NRTL approvals.
• Plan, coordinate, and oversee all required compliance testing activities, including engagement with external test labs and certification bodies.
• Lead submissions, responses, and issue resolution with notified bodies and regulatory agencies.
• Support regulatory filings and product registrations by providing required compliance documentation and technical justifications.

• Provide input to system and subsystem design requirements to ensure alignment with IEC, EN, UL, and other applicable standards.
• Oversee implementation of safety features across electrical, mechanical, and system‑level designs.
• Own safety‑related hardware aspects, including insulation coordination, creepage/clearance, environmental robustness, and user interaction safety.
• Embed compliance considerations early in product development to minimize rework and certification risk.

• Lead and facilitate risk management activities, including FMEA, fault‑tree analysis, and hazard analysis in accordance with ISO 14971.
• Identify gaps against regulatory standards and drive mitigation plans to closure.
• Translate risk and compliance findings into actionable engineering requirements.

• Monitor changes in global regulatory and safety standards and assess impact on existing and future products.
• Develop and execute plans for timely implementation of standard updates.
• Serve as a subject‑matter expert on medical electrical equipment standards (e.g., IEC 60601 series).

• Partner with Quality, Regulatory, and Manufacturing teams to ensure compliant, repeatable, and manufacturable designs.
• Provide compliance guidance to engineering teams throughout the development lifecycle.
• Support internal audits, external inspections, and remediation efforts.
• Mentor junior engineers and contribute to building organizational capability in compliance engineering.

• Develop and maintain technical documentation required for regulatory submissions and audits.
• Ensure accurate traceability between requirements, risk controls, verification, and validation activities.
• Support investigation and resolution of nonconformances, deviations, and field issues related to safety or compliance.

• Personal Excellence – effective communication, professionalism, self‑awareness.
• Strengthening the Team – high performance standards, collaboration, ownership, motivation.
• Drive for Results – financial discipline, business sense, timely high‑quality decisions.

• Bachelor’s degree in Electrical Engineering or related discipline.
• 7+ years of experience in medical device, healthcare technology, or similarly regulated industry.
• Demonstrated expertise with IEC 60601‑1 and applicable collateral and particular standards.
• Direct experience obtaining CE Mark and/or NRTL approvals for complex electromechanical systems.
• Strong knowledge of risk management methodologies (FMEA, hazard analysis, fault‑tree analysis).
• Experience designing and evaluating safety features in electrical and system‑level designs.
• Ability to interpret and apply regulatory and safety requirements to engineering design decisions.
• Strong troubleshooting and root‑cause analysis skills.
• Excellent documentation and technical writing skills.
• Effective communication and collaboration across technical and non‑technical stakeholders.

• Advanced degree in Electrical Engineering or related…