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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, Executive , Cincinnati, Ohio

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