Is accountable for process and Manufacturing Requirements based on Product Specifications and Test Requirements from R&D * Proofs suitability of the selected processes and equipment for production of sterile disposables by means of equipment, test method and process validation * University degree (Bachelor, Master, Diploma) in Industrial/Production Engineering, Polymer Engineering, Mechanical Engineering or related fields * Minimum of 5 years hands-on engineering experience in the medical device industry * Experienced with process (pMap, pFMEA, IQ, OQ, PQ) and test method validation, as well as with statistical sample planning and statistical analysis of measurements
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