Position Overview

Apply knowledge of coating chemistry and processes to the design and development of coated medical devices from feasibility to production. Support coated medical device development with work including writing or verifying specifications, and designing test processes, equipment, and raw materials to ensure that subassemblies and finished products meet their requirements. Work with R&D counterparts, 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:
  • Primary work location is in the R&D laboratory or pilot line cleanroom. Secondary work location is in an office environment.
  • Design and develop new coating procedures for catheters, balloon catheters, stents, guide wires, etc.
  • Review and develop manufacturing documents (MP, Routers, BOM, etc.)
  • Draft and execute validation of product, equipment, test methods, and processes.
  • Perform in vitro simulated use and material testing to determine performance of current, competitive, and proposed coated products.
  • 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 builds for new product development in prototype and pilot production setting, including training of Operators and coordination with Production Planning.
  • Identify and execute on improvements, issues, or any process requirement with minimal supervision.
  • Handle chemicals safely in accordance with approved processes and procedures.
  • Perform other duties and responsibilities as assigned.
    1. Bachelor of Science in Engineering or related field.
    2. Eight (8) to ten (10) years of experience in the coating of medical devices is required.
    3. Strong verbal and written communication skills.
    4. Experience working with manufacturing process development projects and transfer of R&D projects into high volume production.
    5. Ability to design, execute and analyze processes using designs/experiments. Applies critical thinking and comprehensive technical translation in recommending process improvements.
    6. Ability to read and prepare technical documentation, including Manufacturing and R&D procedures, specs, and engineering drawings.
    7. Ability to prioritize and meet deadlines in a timely manner.
    8. Expert proficiency with MS Word, Excel, and PowerPoint.
    Desired Qualifications
    1. Ability to effectively manage internal and external customer relationships as well as leading different key players on achieving a goal.