Requires Bachelors or foreign degree equivalent in Industrial Engineering, Mechanical Engineering, Plastics Engineering, Chemical Engineering, Biomedical Engineering or related field followed by 5 years of progressive related experience. Requires 2 years of experience with working in FDA or regulated manufacturing environment; medical device component manufacturing, including tipping and molding; writing and executing validations including IQ, OQ, PQ, and TMV; CAD Computer Aided Design software; and writing controlled documents for manufacturing, including standard operating procedure SOP and work instruction WI.br br Telecommuting allowed from anywhere in the US. International travel required 20 of the time.

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