Safety & Regulatory Compliance Engineer
GE HealthCare
This listing was originally posted on GE HealthCare's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moResponsible for defining, verifying, and assuring compliance of electrical and electromechanical systems used in medical ultrasound scanning systems with applicable international and national safety, EMC, environmental, and regulatory standards in a highly regulated medical device environment.
Ensuring safety, EMC, environmental, wireless, and regulatory approval of electrical and electromechanical systems for medical ultrasound scanners through specification, design review, testing, and documentation
Addressing compliance of electrical systems, including power electronics, displays, cabling, grounding concepts, enclosures, non‑conductive materials, radio modules, and overall system integration within a medical device context
Supporting compliance activities with external certification and approval bodies, including UL and equivalent institutes, for product listing, regulatory approvals, and wireless certifications (e.g., CE, FCC, and other regional authorities)
Maintaining up‑to‑date knowledge of relevant EU Medical Device Regulation (MDR), applicable directives, international safety and EMC standards, wireless and radio regulations, and worldwide approval requirements for medical equipment
Acting as a technical authority and advisor in safety, wireless, EMC, and regulatory compliance, supporting cross‑functional stakeholders throughout the medical device lifecycle.
Bachelor’s or Master’s degree in Electronic Engineering or a related technical discipline
Advanced experience within safety, EMC, environmental, and regulatory compliance for electronic or electromechanical systems
Experience working with medical devices or other high‑reliability, safety‑critical products in regulated environments
Solid knowledge of IEC 60601 series standards, including electrical safety, EMC, and risk management aspects applicable to medical electrical equipment
Experience with CE marking
Practical experience with EMC, environmental, safety, and wireless compliance testing including collaboration with external test houses and certification bodies
Strong understanding of electrical system behavior, grounding concepts, cabling, enclosures, and system‑level integration from a compliance and safety perspective
Experience reviewing designs and test results in collaboration with Quality Assurance, identifying compliance risks, and advising engineering teams on appropriate mitigation strategies.
Structured, systematic, and analytical approach to compliance activities, including troubleshooting and root‑cause analysis
Self‑driven, motivated, and collaborative team player with the ability to act as a technical authority and share compliance knowledge across disciplines
Excellent written and verbal communication skills in English (Danish is considered a plus)
If you feel your experience does not perfectly align with every qualification listed, we encourage you to apply anyway. We value diverse backgrounds and perspectives, and we are interested in learning how your skills and experience could contribute to this role and our organization.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or, age, disability, protected veteran status or other characteristics protected by law.
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Relocation Assistance Provided: No
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