Create detailed, comprehensive and well-structured V V TEST protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix Design Control ation.
Define Execute the Usability Ergonomic Verification TEST protocols.
Develop, apply maintain TEST methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs product requirements.
Being involved in the reliability and integration tests for prototypes and products.
Maintain relevant chapters of DHF DMR.
Requirements: BA/BSc. Degree in Mechanical / Biomedical or equivalent practical experience.
1-2 Years of proven Verification Process Validation experience in medical device industry with a strong emphasis on problem solving, along with written and verbal skills.
Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA.
Knowledge and experience with environment, safety, bio-compatibility, sterility and essential performance tests (IEC 60601, EN 61508, ISO 10993-5, ISO 11135, etc.).
Solidworks, ERP /PDM
Good documentation skills and ability to communicate effectively at all levels of the organization.
Multi-tasker, independent, punctual and accurate with excellent organizational skills, Team oriented, collaborative, good personal relationships.
Excellent skills in English language are required (verbal and written communication).
.המשרה מיועדת לנשים ולגברים כאחד