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.
- Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.).
- Strong written and verbal communication skills.
- Computer skills including Word, Excel, and PowerPoint.
- Proficiency in SolidWorks (and/or CAD) and fixture/tooling design.
- Ability to read and prepare technical documentation.
- Working knowledge of standard machine shop equipment and process.
- Knowledge of Process Validations in medical device manufacturing environment.
- Good problem solving and conflict management skills.
- Knowledge of medical and technical development.