Entrepreneur. Strategic Thinker. Problem Solver. Teammate.Engaged in project management, process development, and continuous improvement for medical device OE manufacturing. Experience with leading cross-functional teams and managing team members with diverse responsibilities, skills, and proficiency.Core Competency: Leading projects from concept phase or pilot production through transfer to manufacturing.Skills and Experience: process validation, design for manufacturability and assembly (DFMA), risk management (pFMEA), lean manufacturing, six sigma, drafting, documentation control, cGMP, automation, SPC, design of experiments (DOE), feasibility reviews, customer service, change control, first article inspections, project management, root cause analysis, employee training, coaching/mentoring