Position Overview

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.
  • Engineer I, Manufacturing Process Requirements
    1. Bachelor of Science in a related field (e.g., ME, BSChe, EE, IE, PE, etc.)
    2. Strong written and verbal communication skills
    3. Computer skills including Word, Excel, and PowerPoint
    4. Proficiency in SolidWorks (and/or CAD) and fixture/tooling design
    5. Ability to read and prepare technical documentation
    6. Working knowledge of standard machine shop equipment and process
    Engineer II, Manufacturing Process Requirements
    1. Bachelor of science in related field or equivalent experience.
    2. Minimum of two (2) years of related experience.
    3. Strong written and verbal communication skills.
    4. Statistical Knowledge.
    5. Working knowledge of standard machine shop equipment and processes.
    6. Knowledge of medical and technical development.
    7. Proficient computer skills including MS Word, Excel, and Auto CAD.
    8. Knowledge of Process Validations in medical device manufacturing environment.
    9. Ability to read and prepare technical documentation.
    10. Good problem solving and conflict management skills.
    11. Proficiency in SolidWorks and fixture/tooling design.
    Desired Qualifications
    1. Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization preferred.
    2. Green Belt or Black Belt certification.