The requirements listed below are representative of the essential duties required of the Sr Manufacturing Engineer. • Provide DFM and DFT feedback on new products as part of the development team. • Create product workflows and routings. • Create work instructions for internal and external use. • Implement process and design improvements to improve cost, time, and quality. • Develop, implement, verify, and validate manufacturing processes in support of process flow and value stream mapping improvements for existing and new products. • Work with quality on verification and validation procedures to support the launch of commercial manufacturing. • Enhance manufacturing process flow and floor layout to enhance safety, quality, and efficiency. • Work with the product development team to design manufacturing tooling and fixtures. • Work with production and quality on creating procedures and processes to manage external contract manufacturers as well as internal production. • Manage new product introduction and transition from product development to production. • Lead effort to transition manufacturing of subassemblies to contract manufacturer. • Act as the point of contact for resolving technical issues at the contract manufacturer and the production floor.
Education and/or Experience • BS in Engineering or Science required. • Minimum of 7 years' manufacturing experience; in the medical device/FDA regulated industry. Preferably in the capital equipment and or laser field. • Prior experience working with contract manufacturing and transitioning products from design to contract manufacturing. • Working knowledge of the FDA, ISO, and the medical device industry requirements (e.g., FDA QSR, ISO 13485, ISO 14971)