Position Overview

  1. Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
  2. Supports validation of product, equipment and processes.
  3. Interfaces with other departments to solve production problems.
  4. Monitors equipment maintenance program.
  5. Investigation and testing of product processes, NCR’s, DC’ and EO’s.
  6. Drafts and executes validation of product, equipment and processes
  7. Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning
  8. Analyze data and improve processes to assure robust/repeatable manufacturing processes
  9. Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes
  10. Manage process validation and product transfer activities across different manufacturing facilities
  11. Review and develop manufacturing documents (MP, Routers, BOM, etc.)
    1. Bachelor of science in related field or equivalent experience
    2. Three (3) to Five (5) years of related Cardiac or Structural Heart Medical Device experience.
    3. Solidworks experience required
    4. Good communication skills.
    5. Statistical Knowledge (Green Belt or Black Belt a plus).
    6. Computer skills including Word, Excel and PowerPoint