Joining TÜV Rheinland means working for one of the world’s leading testing, inspection, and certification service providers with more than 20,000 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. SUMMARY:
The Senior Test Engineer is responsible for completing all aspects of regulatory compliance testing and reporting of medical device products. This includes developing and implementing test procedures for testing of components, subsystems, and medical device products. This position will also work with other engineers to support compliance activities. Will work directly with lab management providing guidance and assisting with development of the lab.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- May act as lead engineer on complex projects. Participate in setting technical direction; plan schedule and coordinate detailed phases of a project. May train other test engineers and test technicians.
- Must have experience and be able to apply the requirements of medical product safety standards 60601 (national and international), with knowledge of the collaterals and particulars.
- Conduct applicable testing, such as leakage current measurements and defibrillation proof, to the requirements of national and international 60601 series of standards, including applicable collaterals and particulars. Ensure product meets regulatory compliance requirements.
- Perform thorough evaluation, testing and reporting of medical device products.
- Understanding and familiarity of ISO 14971 Risk Management Process, IEC 60601-1-6 and IEC 62366 Usability Engineering Process and IEC 62304 Medical Device Software – Software life cycle processes.
- May assist with defining customer technical requirements, scope, test strategies and selecting test equipment to prepare quotes and proposals.
- Establish and maintain professional relationship with customers. Consult with customer on highly complex issues.
- Liaise with other global laboratories to ensure consistency and accuracy of methods and interpretations.
- Document test results for corrective action, report and audits. Analyze test data and determine expected outcome for tests. Identify and report all deviations.
- Maintain confidentially of all TUV and client information.
- Perform other duties as assigned.
QUALIFICATIONS & REQUIREMENTS:
Knowledge, Skill, & Abilities
- Ability to work in a team environment and able to take direction.
- Advanced engineering knowledge, understanding of testing requirements, manufacturing processes, drawings and standards.
- Excellent communication skills/friendly manner, to relay complex scientific and technical information in a clear, concise, and understandable manner, verbally and in technical writing.
- Advanced analytical, problem solving and troubleshooting skills.
- Knowledge of US and international regulatory standards and approval requirements.
- Demonstrated knowledge of western consumer values and expectations in regards to foreseeable product use and abuse.
- Ability to work in a dynamic environment.
- Ability to organize, prioritize and perform multiple tasks while meeting or exceeding deadlines.
- Ability to travel. Valid driver’s license required.
Education
- Bachelor’s Degree in a technical discipline or equivalent education and/or experience in medical product safety testing.
- Regulatory Testing training.
Experience
- 5 years minimum of test experience and evaluating medical device products in accordance with product regulatory standards.
- Experience using automated test tools.
- Experience testing to NEC, NFPA, UL, CSA, IEC, EN Standards preferred.
PHYSICAL DEMANDS & WORK ENVIRONMENT:
- Office and laboratory environment
Equipment Used:
- Personal Computer
- Electronic test equipment
Travel Required:
- Travel to client locations, when needed.
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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