Masters degree in Mechanical Engineering, Biomedical Engineering, or related field and 3 years of experience involving the following Documenting and executing test protocols for medical device, or combination product development activities, including realtime aging and accelerated aging considerations; Documenting and executing test protocols using a Force Tester such as an Instron using Blue Hill software; Rootcause analysis for test deviations and failures using statistical methods with JMP, Minitab, or equivalent; Demonstrating product development adherence to international regulatory standards such as ISO 13485, ISO 10993, and ISO 14971; and Planning activities for design controls related to medical device development design verification, design validation, and design transfer.br br Section H.14 defines the experience and skills that a qualified candidate must possess to meet the actual minimum requirements for the position. This experience and skills may be obtained in the position offered or any alternate related occupation, regardless of job title
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