Engineer II, Manufacturing Process

Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure that the subassemblies and finished products meet their requirements. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties:

• Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Support validation of product, equipment, and processes.
• Interface with other departments to solve production problems.
• Monitor equipment maintenance program.
• Investigate and test product processes, NCR’s, DC’s and EO’s.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of Assemblers and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.).
• Perform additional duties as assigned.