Engineer II, R&D Process Development
3 weeks ago
Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product process; designing fixtures; and testing process, 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 launch. Job duties:
- Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
- Draft and execute validation of product, equipment, and processes.
- Provide mechanical design concepts for new equipment and fixturing to improve manufacturing process capability, capacity, efficiency, cost, and quality.
- Lead builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
- Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
- Lead projects related to process validation and product transfer activities across different manufacturing facilities and product lines.
- Review and develop manufacturing documents (e.g., MP, Routers, BOM, Drawings, Specifications, etc.).
- Perform additional responsibilities as assigned
Qualifications
- Bachelor of Science degree in Engineering.
- A minimum of two (2) years of relevant medical device and manufacturing process development experience.
- Demonstrated expertise with inferential statistical process analysis techniques.
- Demonstrated expertise with mechanical design methods using SolidWorks.
- Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.
- Proficient with MS Word, Excel, Teams, and Outlook.
- Experience in Process Validations in medical device manufacturing environment.
- Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization.
- Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings.
- Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling.
- Working knowledge of conventional and CNC machining processes.
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