דרושים אייסקיור מדיקל בע"מ

Review specifications and technical design documents to provide timely and meaningful feedback for Engineering Verification & Validation activities.
Ownership & Maintain the company Verification, Validation & Process Validation infrastructure (SOP, Forms, SW tools, Jigs, Simulators).
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 documentation.
Define & Execute the Usability & Ergonomic Verification Test protocols
Develop, apply & maintain test methods, equipment and instruments for medical device throughout all development and production stages of the product to meet user needs & product requirements.
Being involved in reliability and integration tests for prototypes and products.
Developed manufacturing processes and NPI transfer from R&D to manufacturing environment (IQ/OQ/PQ, Validation Plans, Sample size, ATP, Testing forms and Documentation)
Maintain relevant chapters of DHF & DMR
Development and implementation of methodologies for collecting and analyzing field failure data and determining root cause of field failures (FTA, LOGs investigation, SPR, service Failure analysis, etc)
Leading company efforts to eliminate life field failures in products.
Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause
Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure
Incorporating automation and improvement of failure analysis process.