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…Mechanical Engineering, or similar field + >5 years of experience in medical device or diagnostics manufacturing + Demonstrated problem-solving and
…As the program progresses, the individual will contribute to the medical device development process, including developing specifications, testing/verification,
Henry Schein, Inc.
…standards and augments quality system processes to meet changing requirements, including the Medical Device Regulation, US FDA, MDSAP and others as required.
…process improvement experience. **Preferred** + Direct work experience in IVD or medical device /biotech or regulated manufacturing environment. + Process, QMS or
…to write requirements, develop system designs, and develop test protocols. + Design medical device products using various skills and techniques. + Design of
…grasp of microfluidics and its application within real world products + Experience in medical device development and design controls **WHAT WE OFFER** At Abbott,
…+ Knowledge of the clinical IVD testing work environment + Experience in medical device development and design controls + Demonstrated problem-solving and
… medical devices Preferred: * Advanced knowledge of federal and other regulations governing medical device assembly and design, eg GMP, QSR, ISO and CMDR *
…supplier performance. + Knowledge of regulations and standards affecting in vitro diagnostic's device manufacturing. + Medical Device Industry experience. +