Must also have demonstrated experience in the following Medical Device Product Development in the area of disposableinjection molded components and systems; FDA 21 CFR 820 Quality System Regulation; ISO 134852016 Medical Device Quality Systems; SolidWorks CAD; Statistical Analysis techniques using Minitab software for design of experiments and completing complex data analysis; Design of test methods and fixtures through validation including development and execution of gage RR studies; Management of Design History Files DHF and associated documents per Design Control procedures; Design Failure Modes and Effects Analysis dFMEA in risk management process; and Technical writing through the authorship and review of engineering test plans, protocols, and reports.

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