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.
- Bachelor of science in related field or equivalent experience.
- Minimum of two (2) years of related experience.
- Strong written and verbal communication skills.
- Statistical Knowledge.
- Working knowledge of standard machine shop equipment and processes.
- Knowledge of medical and technical development.
- Proficient computer skills including MS Word, Excel, and Auto CAD.
- Knowledge of Process Validations in medical device manufacturing environment.
- Ability to read and prepare technical documentation.
- Good problem solving and conflict management skills.
- Proficiency in SolidWorks and fixture/tooling design.
- Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization preferred.
- Green Belt or Black Belt certification.