Must possess a minimum of 2 years experience with each of the followingbr br The design and manufacture of Class II and Class III medical devices;br Navigating engineering principles within an FDA regulated environment and following ISO13485, ISO14971 and ISO 9001;br Process validation IQOQPQ, DOE and Gage RR;br Design for DRM Design, Reliability, and Manufacturing practices and tools using Solid works modeling software;br Lean manufacturing and Six Sigma methodologies, incorporating GMP Good Manufacturing Practices, 8D Problem Solving and DMAIC Problem Solving;br CAPA Corrective and Preventive Action planning and implementation;br Risk Deliverables to include Use, Design and Process Failure Mode Effects Analysis FMEA and Product Hazard Analysis;br Coordinating studies for cost control, waste reduction, and inventory control and production record systems.

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