Engineer I, Manufacturing Process

Support manufacturing process development and 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 the concepts, sub-assemblies, finished products, and/or prototypes meet 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:

• Improve, sustain, develop, and support of new and existing manufacturing processes for new and existing 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.
• Investigation and testing of product processes.
• Support prototype and pilot production, facilities, and planning when appropriate.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (MP, Routers, BOM, etc.).
• Perform additional duties and responsibilities as assigned.