Project Manager - Sustaining Engineering - Medical Devices

Posted on Sep 12, 2019 by Job Juncture

Cincinnati, OH 45201
Engineering
Immediate Start
Annual Salary
Full-Time
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 focus on sustaining engineering projects leading teams that include 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: 755523792

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