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Project Manager - Tech Transfer - Medical Devices

Posted on Sep 12, 2019 by Job Juncture

Cincinnati, OH 45201
Health Care
Immediate Start
Annual Salary
Full-Time
Highly regarded global medical devices company is seeking a Sr. Project Manager to lead a Class II medical device technical transfer project of significant size and scope. The Sr. Project Manager will lead a cross functional team that includes marketing, service, manufacturing, quality, legal and regulatory.

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 leading cross functional teams including engineers, quality, regulatory
  • Experience with IQ, OQ, PQ - equipment qualification and validation
  • 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.

Reference: 755523859

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