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Project Manager - Tech Transfer - Medical Devices

Company: Affinity Executive Search
Location: Cincinnati
Posted on: September 15, 2019

Job Description:

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: * Bachelors 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.

Keywords: Affinity Executive Search, Cincinnati , Project Manager - Tech Transfer - Medical Devices, Healthcare , Cincinnati, Ohio

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