Senior Testing Engineer; Medical

Position: Senior Testing Engineer (Medical)
Compensation Data

The salary range for this position is $100,000-$115,000 and reflects factors such as years of experience, relevant expertise, and overall qualifications.

Job Summary

Joining TÜV Rheinland means working for one of the world's leading testing, inspection, and certification service providers with more than 25,000 employees globally. Our employees are our most important asset. That is why we invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match. At the same time, we live an international, team-oriented culture characterized by respect, collegiality and openness.

This enables our employees to develop their potential, apply new knowledge and methods directly - and plan a long-term career with real opportunities for advancement.

Job Description

Summary:
The Senior Test Engineer leads regulatory compliance testing and reporting for medical devices. Responsibilities include developing and executing test procedures for components, subsystems, and full products. The role requires deep experience with IEC 60601 and IEC 61010 standards and close collaboration with engineering teams and lab management to support compliance and lab development.
Principal Duties and Responsibilities:

• Lead complex projects, set technical direction, plan schedules, and coordinate project phases.
• Train test engineers and technicians as needed.
• Apply medical product safety standards IEC 60601 and IEC 61010, including collaterals and particulars.
• Conduct regulatory compliance testing and perform detailed evaluation, testing, and reporting.
• Utilize ISO 14971, IEC 60601-1-6, IEC 62366, and IEC 62304 processes.
• Assist in defining customer requirements, test strategies, and equipment selection for proposals.
• Maintain strong internal and external customer relationships and provide expert consultation.
• Coordinate with global labs to ensure consistent methods and interpretations.
• Document results, analyze data, identify deviations, and support corrective actions.
• Apply CB requirements (OD-2044, OD-2048, OD-5010, OD-5013, OD-5014).
• Participate in proficiency testing and maintain confidentiality of all TUV and client information

Education

University Degree in Medical Studies or related field of study
Experience & Further Qualifications

• Minimum 7 years testing and evaluating medical devices to regulatory standards.
• Direct experience with IEC 60601-1-6,
  -1-8,
  -1-11,
  -2-2,
  -2-18,
  -2-22,
  -2-34; additional collateral/particular experience preferred.
• Experience with automated test tools and testing to NEC, NFPA, UL, CSA, IEC, and EN standards.
• Bachelor's degree in a technical field or equivalent experience in medical product safety testing.
• Regulatory testing training.
• Strong teamwork skills and ability to follow direction.
• Advanced engineering knowledge, testing requirements, manufacturing processes, and standards.
• Excellent communication skills for conveying complex technical information.
• Strong analytical, problem-solving, and troubleshooting abilities.
• Knowledge of U.S. and international regulatory standards.
• Understanding of consumer expectations and foreseeable product use.
• Ability to work in a dynamic environment, manage multiple tasks, and meet deadlines.
• Ability to travel; valid driver's license required.

TUV Rheinland North America EEO Statement
As a global business, TUV Rheinland North America relies on diversity of culture and thought to deliver on our goal of Creative People, Practical solutions serving our client needs, and ensures nondiscrimination in all programs and activities in accordance with Title VI and VII of the Civil rights Act of 1964. We continuously seek talented, qualified employees in our world-wide operations regardless of race, color, sex/gender, including gender identity and expression, sexual orientation, pregnancy, national origin, religion, disability, age, marital status, citizen status, protected veteran status, or any other protected classification under country or local law.

TUV Rheinland North America is proud to be an Equal Employment Opportunity/ Affirmative Action Employer/ Federal Contractor desiring priority referrals of all protected veterans for job openings.

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