Engineer II, Process Development

Position Overview

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

Job Details

    1. Bachelor of Science degree in Engineering.
    2. A minimum of two (2) years of relevant medical device and manufacturing process development experience.
    3. Demonstrated expertise with inferential statistical process analysis techniques.
    4. Demonstrated expertise with mechanical design methods using SolidWorks.
    5. Strong written and verbal communication skills, organizational skills, and ability to work in a fast-paced, self-directed environment.
    6. Proficient with MS Word, Excel, Teams, and Outlook.
    Desired Qualifications
    1. Experience in Process Validations in medical device manufacturing environment.
    2. Experience in statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization.
    3. Solid proficiency in technical documentation, including advanced CAD modeling and engineering drawings.
    4. Demonstrated expertise related to mechanical design of manufacturing equipment, fixturing, and tooling.
    5. Working knowledge of conventional and CNC machining processes.