Requires a Masters degree or foreign equivalent in Biomedical, Mechanical or closely related engineering field and 4 years of experience with RD engineering for medical devices.br br Must possess at least 4 years of experience in each of the followingbr br ISO 9001, ISO 13485, ISO 14971 and cGMPbr Process Development and Product development lifecyclebr DOE, SPC, QSR, and IQOQPQbr Riskbased failure mode analysis including PFMEA, PFMECA and DFMECAbr AutoCAD, Solid Works, VRAR Technology, and ToolingFixturing Development for manufacturing processbr Process characterization, Process Qualification, and Validation Activitiesbr Lean and Six Sigma practices to include DMAIC process and root cause analysis, 5S methodology, scrap reduction, process simplification, Cell Operating Systems, and yield improvementsbr CAPA and NCMRbr Statistical Techniques and DRM practices, including Control and Capabilitybr Technology Identification and Equipment Development
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