Senior Testing Engineer (Medical)

Jobbeschreibung

Senior Testing Engineer (Medical) 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 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.