Requires Masters degree or foreign equivalent in biomedical engineering, mechanical engineering, or a closely related engineering discipline plus 4 years of occupational experience in a medical device manufacturing or another highly regulated industry. Employer will also accept a Bachelors degree or foreign equivalent in biomedical engineering, mechanical engineering, or a closely related engineering discipline plus 6 years of progressive occupational experience in a medical device manufacturing or another highly regulated industry. Additional skills to include Computer technology experience including MS Office applications; statistical software experience including minitab; experience with CAD software such as Creo or SolidWorks; experience in sterile packaging and transportation testing; experience with implant coatings; experience with design transfer of product manufacturing; experience with risk management per ISO 14971; experience with biocompatibility per ISO 10993; experience with statistical process capability; experience with gauge design; experience with cleaning and process validations; experience performing duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485. Travel Requirement Up to 10 domestic travel for training and also to supplier visits to work with them on requirements, inspection methods, and process validations.
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