Job Function Summary: Evaluates, recommends, and implements test strategies, methods and tools. Responsible for test development, test maintenance and test troubleshooting required for support in evaluation activities of current and new medical devices.
- Responsible for standardization of test methods for evaluating and comparing devices and components.
- Evaluation and documentation of device compliance to defined regulations.
- Test equipment maintenance, performance optimization, implementation and monitoring.
- Creation of test plans, test reports and all other documentation required for the development and implementation of test fixtures and/or test systems.
- Play an integral role in creation of test strategies and infrastructures; design, debug, and qualification of test equipment; identify resource requirements necessary for completion of assigned tasks and/or projects.
- Aid in, support and prepare for FDA submissions.
- Contributes to the team effort by accomplishing related tasks as necessary.
Required Knowledge, Skills and Abilities:
- Demonstrated project management experience.
- Direct experience in medical device industry is required.
- Bachelor's Degree in Engineering or related discipline, or equivalent work experience.
- A minimum of three years progressive experience. High level of attention to detail with good testing and troubleshooting skills.
- Strong computer skills including MS Office (Excel, Word) applications and statistical programs such as MiniTab are required.
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