• Lead mechanical design of disposable device components from concept through production, including CAD modeling, design specifications, drawings, tolerance analysis, GD&T, and verification planning.
• Design plastic components for high-volume manufacturing, with emphasis on injection molding, manufacturability, dimensional control, component robustness, cost, and scalability.
• Partner with suppliers, tooling vendors, and contract manufacturers to evaluate design tradeoffs, resolve manufacturability issues, support process validation, and transition designs into production.
• Own sustaining activities for disposable components and serve as the technical lead for manufacturing and supplier component performance issues, including design change requests.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to demonstrate performance against design requirements.
• Create and maintain design control documentation, including requirements, specifications, drawings, risk documentation, design reviews, investigations, and regulatory inputs.
• Collaborate across engineering, manufacturing, quality, regulatory, procurement, and commercial teams while providing technical guidance to junior engineers and cross-functional partners.