Lab Test Validation Engineer
- Engineering
- Senior
Our client is a globally operating supplier of Engineering Services. The company was established 30 years ago and employs 2000+ staff working in 12 global offices and multiple client locations. Clients are mostly large companies in industries like Transportation, Industrial machinery, Healthcare and Hi-Tech. Services include product design & development, embedded software, manufacturing engineering and data management & analytics. The vision of the company is to become the most preferred Technology Services partner for global companies who are leading innovation in the intersection of the digital and physical worlds.
Job description
- Setting up test protocols based on standards and product requirements.
- Executing tests, and documenting product test results
- Sample size determination based on confidence levels
- Carry out Risk analysis and Risk control measurement.
- Writing Test case for medical Devices (mainly Applicators).
- Good Knowledge of REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT.
- Identifying the hazards situation and risk control Measure.
- Verification of the Product against requirement and in term Customer requirement.
- Do Documentation of test results in Polarion
- Good Communication Skills"
Qualification & Skills
Person who knows Mechanical / Physical testing of Medical Devices. She/He have previous experience to Validation, Quality check & regulation as per EU medical domain. Having experince to programing Polarion or similar software would be good to have
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