2 - 7 years
3.5 - 8.5 Lacs P.A.
Bengaluru
Posted:1 month ago| Platform:
Work from Office
Full Time
Position Summary: Senior Engineer/ Test Engineer is responsible for regulatory compliance testing and reporting of medical device products. This role involves developing and implementing test procedures, conducting various tests, and ensuring products meet regulatory standards. The engineer will collaborate with other engineers, lab management, potentially leading complex projects and training junior engineers. Bachelor's Degree in a technical discipline or equivalent education and/or experience in medical product safety testing. Should have 3-5 years minimum of test experience evaluating medical device products in accordance with product regulatory standards. Complete all aspects of regulatory compliance testing and reporting of medical device products in in accordance with International and European standards. Roles and responsibilities: Conduct electrical safety testing based on the standard series IEC 60601-1/IS 13450-1, including all particulars and collaterals. Develop and implement test procedures for components, subsystems, and medical device products. Act as lead engineer on complex projects and set technical direction. Plan schedule and coordinate detailed phases of projects. Ensure products meet regulatory compliance requirements. Perform thorough evaluation, testing, and reporting of medical device products. Assist in defining customer technical requirements and selecting test equipment for quotes and proposals. Establish and maintain professional relationships with customers and consult on complex issues. Liaise with laboratories for consistency and accuracy of methods and interpretations. Document test results for corrective action, reports, and audits. Analyze test data and determine expected outcomes for tests. Identify and report all deviations. Train other junior test engineers and test technicians. Maintain confidentiality of all TUV SUD and client information. Interested candidates, please email updated resume to basavaraj.ym@tuvsud.com Thanks & Regards, TUV SUD
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