Product Safety Engineer 1 1

At TUV SUD we are passionate about technology. Innovations impact our daily lives in countless ways, and we are dedicated to being a part of that progress. We test, we audit, we inspect, we advise. We never stop challenging ourselves for the safety of society and its people. We breathe technology, we strive for professional excellence, and we leave a mark. We take the future into our hands. We are TUV SUD.

• Support electrical safety evaluations and testing activities for medical electrical equipment and in-vitro diagnostic devices in accordance with applicable national and international standards.
• Perform routine electrical safety testing including leakage current, dielectric strength, temperature, abnormal operation, mechanical hazards, grounding continuity, and EMC pre-compliance evaluations.
• Assist with product assessments and component evaluations for medical devices to standards such as IEC/UL/EN 60601-1, IEC 60601-1-2, IEC 61010-1, and related collateral and particular standards.
• Review technical documentation including schematics, risk management files, bills of materials, insulation diagrams, user manuals, and labeling for compliance with regulatory and certification requirements.
• Support testing and certification activities for products such as patient monitoring systems, laboratory equipment, diagnostic devices, wearable medical devices, infusion pumps, imaging accessories, and connected healthcare products.
• Prepare accurate test records, engineering notes, and technical reports under the guidance of senior engineers.
• Communicate project progress, technical findings, and testing requirements with clients and internal teams.
• Support laboratory operations including test setup preparation, calibration coordination, equipment maintenance, and ISO/IEC 17025 quality activities.
• Participate in training activities related to medical device safety standards, regulatory compliance, and certification programs.

• Bachelor of Science degree in Electrical Engineering, Biomedical Engineering, Electronics Engineering, or related technical discipline preferred.
• 2-5 years of experience in electrical product safety testing, medical device compliance, or laboratory environments.
• Working knowledge of medical electrical equipment standards including IEC/UL/EN 60601-1 and familiarity with IEC 60601-1-2 EMC requirements preferred.
• Experience using laboratory instrumentation such as oscilloscopes, hipot testers, leakage current analyzers, multimeters, environmental chambers, and power analyzers.
• Basic understanding of medical device certification and regulatory pathways including NRTL, CB Scheme, CE Marking, and FDA considerations.
• Familiarity with risk management concepts per ISO 14971 is preferred.
• Strong analytical, troubleshooting, and documentation skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects in a fast-paced laboratory environment.
• Proficiency in Microsoft Word, Excel, and technical reporting systems.

• Opportunity to work with a global leader in medical device testing and certification.
• Collaborative and inclusive engineering environment.
• Hands-on mentorship and professional development opportunities.
• Exposure to innovative healthcare technologies and international regulatory programs.
• Competitive compensation and benefits package.

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  The anticipated base pay range for this full-time position is $60,000- 95,000 annually. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, up to 12 weeks of paid parental leave for birthing parents and 2 weeks for other parents, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.
  
  
• Travel: Occasional travel required to client or TUV SUD sites.
• Physical requirements: ability to lift/move up to 75 pounds occasionally; ability to sit, talk, hear, and use hands/fingers for extended periods.
• Work model: On-site
• We welcome applications from people of all backgrounds, experiences, and perspectives.

Equal Opportunity Employer - Disability and Veteran

TUV SUD America, Inc. is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.