Currently managing a growing team of 9 manufacturing engineers and 4 technicians to support all manufacturing engineering activities for both New Product Introduction (NPI) and Sustaining at the Mansfield site for Paragon Medical (previously Bridgemedica). This site within Paragon is a contract manufacturer for a diverse portfolio of products/processes which my team is responsible for the process development, validation, and sustaining/CI activities to meet FDA cGMP and ISO regulations.

•Led cross functional project teams to ensure products and associated disposables met or exceeded all applicable industry and company requirements and declarations•Proposed and implemented VAVE projects including component material changes, supplier and in-house process changes and standardization activities resulting in component cost, inventory and production time reductions•Coordinated with suppliers to identify and facilitate supply continuity projects and resolved 100% of presented quality issues through root cause analysis with no production line down time•Designed new or updated existing components or tools using SolidWorks and created new or updated existing processes to meet project goals•Managed all technical documentation such as drawings, specifications, BOMs, tolerance assessments, V&V protocols and reports, manufacturing instructions and service procedures•Addressed audit findings of internal/external complaints through CAPAs and implemented corrections in a timely manner which resulted in Smith’s Global best practice finding•Developed all applicable support documentation and coordinated with all stakeholders to ensure engineering change order (ECO) implementation•Provided engineering support to manufacturing/quality for all aspects of production and service