Product Safety Engineer 1

Job Description

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Product Safety Engineer 1

At TÜV SÜD Group 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 TÜV SÜD Group.

Medical Device Safety Test Engineer (f/m/d)

Location: United States

Business Unit: Medical Device Testing

Work Model: Onsite/Hybrid based on business needs

Employment Type: Full-Time

Your Tasks

As a Medical Device Safety Test Engineer, you will support the evaluation, testing, and certification of medical electrical equipment and in-vitro diagnostic devices. Working closely with customers, laboratory personnel, and senior engineers, you will help ensure products meet applicable safety, electromagnetic compatibility (EMC), and regulatory requirements for global market access.

• Perform electrical safety testing and evaluations for medical devices in accordance with applicable national and international standards.
• Conduct testing activities including leakage current, dielectric strength, grounding continuity, temperature evaluations, abnormal operation testing, mechanical hazard assessments, and EMC pre-compliance evaluations.
• Support compliance assessments 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, bills of materials, insulation diagrams, risk management files, product labeling, and user manuals.
• Support testing and certification projects involving patient monitoring systems, laboratory equipment, diagnostic devices, infusion pumps, wearable medical devices, imaging accessories, and connected healthcare products.
• Prepare accurate test records, engineering documentation, and technical reports under the guidance of senior engineering staff.
• Communicate project status, test findings, and technical requirements to customers and internal stakeholders.
• Support laboratory operations through test setup preparation, calibration coordination, equipment maintenance, and quality system activities.
• Participate in training and professional development activities related to medical device standards, regulatory requirements, and certification programs.

Your Qualifications

Required Qualifications

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Electronics Engineering, or a related technical discipline.
• 2 to 5 years of experience in electrical product safety testing, medical device compliance, laboratory testing, or a related technical environment.
• Knowledge of electrical safety principles and test methodologies.
• Experience using laboratory instrumentation such as oscilloscopes, multimeters, hipot testers, leakage current analyzers, environmental chambers, and power analyzers.
• Strong analytical, problem-solving, and troubleshooting skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and priorities in a fast-paced technical environment.
• Proficiency with Microsoft Office applications and technical reporting systems.

Preferred Qualifications

• Working knowledge of IEC/UL/EN 60601-1 and related medical electrical equipment standards.
• Familiarity with IEC 60601-1-2 EMC requirements.
• Understanding of medical device certification pathways, including NRTL, CB Scheme, CE Marking, and FDA regulatory considerations.
• Familiarity with risk management principles and ISO 14971 requirements.
• Experience supporting testing and certification activities for medical devices.
• Experience working within ISO/IEC 17025 accredited laboratory environments.

What We Offer

• Opportunity to work with a globally recognized leader in testing, inspection, and certification services.
• Exposure to innovative medical technologies and global regulatory requirements.
• Collaboration with experienced engineers, technical experts, and industry leaders.
• Professional development, technical training, and career growth opportunities.
• Hands-on experience supporting the safety and compliance of life-changing medical products.
• Competitive compensation and comprehensive benefits package.
• An inclusive culture focused on quality, innovation, customer service, and continuous improvement.

Additional Information

Work Model: Onsite/Hybrid based on business needs

Location: United States

Compensation & Benefits

The anticipated annual base pay range for this full-time position is $90,000 - $120,000. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, geographic location, market conditions, and internal equity.

The compensation package may also include an annual incentive opportunity, subject to eligibility and applicable plan terms.

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 coverage, employee assistance programs, and generous paid time off.

We welcome applications from individuals of all backgrounds, experiences, and perspectives and are committed to fostering an inclusive workplace where employees can thrive and grow professionally.

TÜV SÜD is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

Equal Opportunity Employer - Disability and Veteran

TÜV SÜD 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.