- Extensive knowledge over 25 years of medical device product/package design & development, quality methods, and business principles in product protection.- High-level project management; leading cross-functional teams during product development & manufacturing implementation; and support of MFG in cost saving, quality & process improvements. - Manufacturing systems used: Horizontal & Vertical Form/Fill/Sealers, Rigid blister tray sealers, Heated bar or movable band induction sealers for Chevron Peel Pouches/Header & tear bags (using poly-poly, poly-Tyvek®, and poly-paper). - Rigid materials used: PETG, Polypropylene, Polycarbonate, High Impact Polystyrene. - Flexible materials used: Low Density Polyethylene, Linear LDPE, HDPE, Nylon, PVC, Foil. - Special oxygen and moisture barrier materials used with multi-layer film laminates: SiOx, EVOH, Aclar®.Specialties: - Experienced in affects of gamma radiation / gas plasma / ethylene oxide / steam / H2O2 sterilization on medical packaging materials.- Manufacturing Process Verification and Validation (DOE, IQ, OQ, PQ)- Knowledgeable in Packaging Regulatory areas: FDA 21 CFR 801 & 820 / ISO 9001, 13485, 11607-1 & 11607-2 / EN 980 & 868Training:- FDA Design Control and Verification Requirements for Medical Device Industry- Six Sigma Process Excellence training- Lean Sigma green belt training- Failure Mode and Effects Analysis- Statistical Process controls - EU MDR requirements
Listed skills include Packaging, Packaging Engineering, Project Planning, Project Execution, and 45 others.