Manufacturing Engineer responsible for troubleshooting and improving production equipment and processes in a medical device manufacturing environment. Leads root-cause investigations, CAPAs, equipment qualifications, process validations, NPI, Lean initiatives, engineering changes, fixture design, and facility layout improvements. Creates manufacturing documentation, supports audits and compliance activities, analyzes process data, and collaborates with quality, operations, customers, suppliers, and cross-functional teams to improve safety, quality, throughput, reliability, and cost.

Leads complex medical device manufacturing programs, including new product introductions, product transfers, cost reductions, integrations, insourcing, and strategic initiatives. Manages cross-functional teams, customer relationships, budgets, schedules, risks, regulatory compliance, corrective actions, and delivery milestones across multiple manufacturing sites. Requires extensive program management experience, medical device manufacturing knowledge, expertise in plastics, tooling, metals, automation, and PMP certification.