Position Overview

Supports manufacturing of products for medical devices with work including writing or verifying specifications, maintaining product process, designing fixtures, test 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 launch. Job duties:
  • Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
  • Drafts and executes validation of product, equipment and processes.
  • Provide mechanical design concepts for new equipment and fixturing to improve mfg. 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.
  • Analyze data and improve processes to assure robust/repeatable manufacturing processes.
  • Confers 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 (MP, Routers, BOM, Drawings, Specifications, etc.).
    1. Bachelor of Science in Engineering
    2. Three to six (3-6) years of medical device and mfg. process development experience.
    3. Demonstrated expertise with inferential statistical process analysis techniques.
    4. Demonstrated expertise with mechanical design methods using Solidworks.
    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 mfg. equipment, fixturing, and tooling.
    5. Knowledge of mechanical design with SolidWorks.
    6. Working knowledge of conventional and CNC machining processes.
    7. Must have good written and verbal communication skills, be well-organized, ability to work in a fast-paced self-directed environment.