Medical Device Product Safety Engineer

Your Tasks

• 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.

Your Qualifications

• 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.

What We Offer

• 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.

Additional Information

• 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 TÜV SÜD 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.