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 for launch and continue leading product sustaining. Typical job duties:
  • Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures
  • Review and develop manufacturing documents (MP, Routers, BOM, etc.)
  • Drafts and executes validation of product, equipment and processes
  • Interfaces with other departments to solve production problems
  • Manages 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
  • Manage process validation and product transfer activities across different manufacturing facilities
  • Investigation and testing of product processes, NCR’s, DC and EO’s
  • Performs other duties and responsibilities as assigned.
  • Identify and execute on improvements, issues or any process requirement with minimum supervision.
  • Able to lead interdepartmental team on achieving goals.
    1. Bachelor’s Degree in Mechanical Engineering or Material Science Engineering
    2. A minim of four (4) years of medical device industry experience.
    3. Experience with Guidewire and Balloon Catheters.
    4. Statistical Knowledge (Green Belt or Black Belt)
    Desired Qualifications
    1. Ability to use and apply lean management principles to analyze, improve and create engineering project and quality procurement systems
    2. Strong communication skills and ability to effectively manage internal and external customer relationships as well as leading different key players on achieving a goal
    3. Experience working with manufacturing process development projects and transfer of R&D projects into high volume production
    4. Ability to read and prepare technical documentation, including manufacturing procedures, specs and engineering drawings
    5. Expert proficiency with MS Word, Excel, PowerPoint, SolidWorks and/or other CAD systems
    6. Ability to prioritize and meet deadlines in a timely manner