Job DescriptionSUMMARY: 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.
REPORTING TO/DEPARTMENT: Reports to the Director, Systems Engineering in the Systems Engineering & Applied Science department
ESSENTIAL DUTIES AND RESPONSIBILITIES: Regulatory & Certification Management- 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
Design for Compliance & Safety- 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
- Ensure compliance considerations are embedded early in product development to minimize rework and certification risk
Risk Management & Analysis- 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
Standards Monitoring & Implementation- Monitor changes in global regulatory and safety standards and assess impact to 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)
Cross-Functional Collaboration- 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
Documentation & Compliance Support- 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
CORE COMPETENCIES:- Personal Excellence
- Effective in communication, demonstrates professionalism at all times, and has an accurate picture of self
- Strengthening the Team
- Demonstrates high performance standards and effectively collaborates with the team, demonstrates a sense of ownership over assigned deliverables, and shows a high degree of motivation toward achieving individual and team goals
- Drive for Results
- Applies financial discipline and a good business sense, supports change, and makes high quality and timely decisions
REQUIRED QUALIFICATIONS:
- 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 skills across technical and non-technical stakeholders
Preferred or Desired:- Advanced degree in Electrical Engineering or related field
- Experience working within ISO 13485 and FDA Quality System Regulations (21 CFR Part 820) environments
- Familiarity with global regulatory frameworks (e.g., EU MDR, FDA submissions)
- Experience working directly with notified bodies or certification agencies
- Proficiency in schematic design and understanding of embedded systems and firmware interactions
- Experience supporting audits, inspections, and regulatory findings
- Project management experience leading cross-functional initiatives
WORKING CONDITIONS- Indoor Environment: The position takes place indoors, providing a comfortable and climate-controlled workspace.
- Physical Demands: This role may involve standing or walking for extended periods of time, requires manual dexterity and the ability to handle delicate, high-value equipment. Ability to lift and carry equipment or materials required.
- Work Schedule: Standard working hours are Monday through Friday; however, evening, weekend or other work outside normal business hours and overtime may be required.
- Computer Usage: Proficiency with computers, including software applications and communication tools, is essential for tasks and collaboration.
- Personal Protective Equipment: Must wear appropriate personal protective equipment (PPE) and ahere to safety protocols and cleanliness standards.
To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship. 
