מהנדס/ת V&V לחברת מדיקל מובילה קיסריה 225939
מהנדס/ת V&V לחברת מדיקל מובילה קיסריה 225939
17/05/2023Ownership & Maintain the R&D Verification & Validation infrastructure (SOP, Forms, SW tools, Jigs, Simulators). Maintain relevant chapters of DHF & DMR.
Create detailed, comprehensive, and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference with Risk Analysis Matrix & Design Control documentation.
Define & Execute the Usability & Ergonomic Verification Test protocols
meaningful feedback for Verification & Validation activities
Develop, apply & maintain test methods, equipment, and instruments for medical devices throughout all product development and production stages to meet user needs & product requirements.
Leading projects to develop, coordinate and execute S
Requirements:
BA/B.Sc. Degree in Mechanical\Biomedical or equivalent
:practical experience
1-3 Years of proven experience in SW & HW, V&V tasks, including writing & executing test plans and protocols, in the medical device industry with a strong emphasis on quality assurance and problem-solving, along with written and verbal skills. Formal and practical knowledge of testing methodologies.
Knowledge of Medical Device Quality Systems, ISO 13485 & CFR21, Design Control, Design, and Development Usability procedures. Experience with the environment, safety, biocompatibility, and essential performance tests (IEC 60601, EN 61508, etc.)
Familiar with LabView, Solidworks, Solid E-PDM - Advantage
* משרה מס׳ #225939 מיועדת לגברים ונשים כאחד
משרה זו סגורה ולא ניתן לשלוח אליה קורות חיים.