◾ Job Description:
– Create detailed, comprehensive, and well-structured V V TEST protocols and reports, with the ability to maintain and cross-reference them with Risk Analysis Matrix Design Control ation.
– Define and execute the Usability Ergonomic Verification TEST protocols.
– Develop, apply, and maintain TEST methods, equipment, and instruments for the medical device throughout all development and production stages of the product to meet user needs and 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 the 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, and 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, and good personal relationships.
– Excellent skills in the English language are required (verbal and written communication).
* This position is open to all candidates.
Please send CV with job number 1049:
📩 Tag-hr@tag-med.com
