Experienced Manufacturing Engineer (~11 years) with a demonstrated history of working in the medical device industry (startup, midsize, large companies). Experience working in both disposables and capital equipment. Skilled in process validation, process development, equipment qualification, process improvement, production scale up and data analysis. Experienced in leading and managing projects with work travel experience and audit support experience.Summary of Experience:• Leadership/Project Management experience • Experience mentoring and managing junior engineers and technicians• Work Travel Experience• Qualifying equipment at Supplier, outsourcing manufacturing processes to supplier, and inheriting manufacturing process from an acquisition • Front Room and Backroom Audit Support Experience – DEKRA, FDA, TUV• Engineering Software – Minitab, SolidWorks, Microsoft Project, Microsoft Excel, SAP, PDM• Sustaining, New Product Introduction, Equipment, Process Validation (IQ, OQ, PQ), and Process Characterization experience• Authored and maintained pFMEA risk documentation• Hydrophilic Coating Development Subject Matter Expert