Apply on Employer Site

GE HealthCare · 16 hours ago

Lead Product Safety Engineer

Salt Lake City, UT

Full-time

Onsite

Senior Level, Lead/Staff

5+ years exp

GE HealthCare is focused on ensuring product safety and regulatory compliance for its medical equipment throughout the product lifecycle. The Lead Product Safety Engineer plays a critical role in collaborating with cross-functional teams to integrate safety requirements and maintain compliance, ensuring patient safety across global markets.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

Responsibilities

Drive certification and compliance activities per IEC 60601-1 series and other relevant standards (IEC, CSA, FDA, EU, NMPA)

Develop test plans and define scope and resources required for safety and regulatory testing

Perform and/or witness safety tests, review raw data, and author test reports

Interface with certifying agencies (CSA, NRTL) to ensure test scope, execution, and acceptance of results

Mentor engineers on safety standards, regulatory requirements, and testing protocols

Identify and resolve safety and compliance issues across the product lifecycle

Support recurring factory inspections and ISO 17025 accreditation for internal labs under WMTC / CB Scheme

Maintain up-to-date knowledge of evolving standards and regulatory requirements

Drive process improvements within safety engineering and ensure audit readiness

Comply with GEHC Quality Manual, QMS, and applicable regulations

Complete all required Quality & Compliance training on time

Ensure accuracy, completeness, and archival of test data per QMS and Good Documentation Practices

Verify calibration and proper operation of test equipment

Maintain impartiality, confidentiality, and integrity in all testing activities

Follow EHS policies and proactively address safety concerns

Qualification

IEC 60601-1 standardsMedical device regulationsISO/IEC 17025Quality Management SystemsRequirements management toolsAnalytical skillsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointProcess improvement toolsEnglish communicationProblem-solving skillsLeadership skillsOrganizational skillsAdaptability

Required

Bachelor's degree in Engineering, Physics, or related field and 5+ years experience with medical device development OR 10+ years in medical device engineering/compliance with 3+ years IEC testing experience

Working knowledge of IEC 60601-1 standards and medical device regulations

Understanding of ISO/IEC 17025 for testing and calibration labs

Familiarity with Quality Management Systems

Strong analytical, problem-solving, and leadership skills

Proficiency in Microsoft Word, Excel, and PowerPoint

Experience with requirements management tools (e.g., DOORS, JAMA)

Excellent English communication skills (oral and written)

Preferred

Hands-on experience with GEHC Surgery Mobile fluoroscopic X-ray C-arm systems

Understanding of risk management, usability, labelling, X-ray, electrical, mechanical, software, wireless, EMI/EMC, AI/ML, and environmental safety and regulatory compliance principles in complex systems

Prior participation in IEC 60601-1 committees and/or product safety societies

Experience in ISO/IEC 17025 accredited or IECEE-based CTF labs

Previous work in the medical device industry

Strong organizational skills and ability to manage multiple priorities

Familiarity with process improvement tools, automation tools, and digital solutions for safety process optimization

Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations

Benefits

Relocation Assistance Provided: Yes

Company

GE HealthCare

Glassdoor4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees