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Sr Test Engineer – Medical Devices

4 months ago

Pleasanton, United States Novo Full time

Our client is the world’s leading testing, inspection, and certification service providers with more than 20,000 employees globally. They invest in their development and offer competitive pay, multiple health insurance plan options, and a 401(k) with up to 6% company match.


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.

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.