Description
Career Summary * Over a decade of experience as a Project Manager, primarily in the medical device industry, and inclusive of the following professional skills: * Project Management and New Product Development * Product Design & Engineering (for manufacturability, DFM) and Engineering Change Control * GMP, Good Manufacturing Practice, and Lean Six Sigma Manufacturing * Process Development and Statistical Process Control * IQ/OQ/PQ Validation Protocols, Reports, and Analyses, Quality Management, Custom Test Equipment and Inspection Fixtures * Regulatory Compliance (with ISO 13485 Global Standards and FDA Class I, II, and III requirements), FMEA and APQP Risk Analyses * Supply Chain Management, Scheduling, Production Planning, Material Validation, and Vendor/Supplier Qualification * Fifteen years experience writing standard operating procedures, manufacturing instructions, quality documents, and training personnel * Over two decades of experience drafting with AutoCAD for engineering, mechanical, architectural, and civil engineering applications