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Project Manager - Sustaining Engineering - Medical Devices

Company: Cameron Craig Group
Location: Cincinnati
Posted on: September 14, 2019

Job Description:

Highly regarded global medical devices company is seeking a Sr. Project Manager to lead a cross functional team in the production of Class II medical devices.-- The Sr. Project Manager will support manufacturing and focus on sustaining engineering projects involving design changes, failure investigations, risk analysis, Device Master Record changes, equipment validations and non-conformance activities.
--
Requirements for Sr. Project Manager:


  • Bachelor's degree in mechanical engineering or materials engineering, advanced degree preferred
  • 7+ years progressive experience in the development of medical devices with a depth of experience in sterile medical disposables, such as syringes, catheters or tubing sets
  • Strong project management skills and a track record of accomplishment in managing cross functional teams including engineers, quality, regulatory
  • Experience with equipment qualification and validation, failure analysis, FMEA and non-conformance processes
  • Demonstrated leadership abilities, strong organizational and planning skills.
  • Strong technical background capacities in supplier management, vendor interface.
  • Exceptional project management skills throughout the project timeline, from concept to qualification and launch.
  • Strong understanding and background of ISO 13485, FDA 21CFR820, and other pertinent standards to the sterile medical disposable, including packaging, sterilization, biocompatibility
  • Excellent leadership skills with demonstrated ability to work in a team environment with R&D, manufacturing, marketing, sales, service, regulatory and quality.

Keywords: Cameron Craig Group, Cincinnati , Project Manager - Sustaining Engineering - Medical Devices, Healthcare , Cincinnati, Ohio

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