Senior Testing Engineer (Medical)

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., * 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

Do you have a valid Driver's License license?, Do you have experience in Regulatory compliance?, Do you have a Bachelor's degree?, University Degree in Medical Studies or related field of study, * 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.

$100,000 - $115,000 a year Health insurance, 401(k) matching, Employee discount, 401(k) 6% Match, Opportunities for advancement Pleasanton, CA 94566, The salary range for this position is $100,000-$115,000 and reflects factors such as years of experience, relevant expertise, and overall qualifications., * Positive working atmosphere: Isn't it tempting to work for an established, significant company with a rich heritage? Here's the even better news: we also want the work to be fun!

• Employee discounts: Exclusive employee offers at attractive conditions are just one of the great benefits we offer you. Please enquire about the details in a personal meeting.
• Bonus programmes: We believe in rewarding performance by recognising success. Let's talk about the details of our bonus programmes in a personal meeting.
• Experienced and international teams: We welcome new talent, but are also proud of our many long-standing colleagues. Let your personal experience come together with our multicultural TÜV Rheinland experience to achieve something together!
• Insurance packages and health care: We are proud to save lives with our work. The physical and mental well-being of our employees is just as important to us! We would be happy to inform you about our insurance and health packages in a personal meeting
• Employee training and development: We live 'Just right' as the core of our corporate DNA. Constantly growing together and learning from each other is therefore a matter of course for us!

In the Products business unit at TÜV Rheinland, we are looking for talents who want to stand with us at the forefront of safety, quality, and innovation. Our goal is to make products safe and compliant with standards in international markets - from consumer goods to highly complex medical devices. In doing so, we support companies in complying with national and international standards. Our focus is on the challenges of digitalization, sustainability, and global trade requirements. Whether smart technologies, sustainable materials, or the safety of connected products - we actively shape the future of product safety., At TÜV Rheinland, you can contribute and expand your expertise in an international environment. We offer a dynamic work environment that fosters innovation, embracing diversity and continuous learning. Together, we shape a future where safety and quality go hand in hand., 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.