Project Manager - Tech Transfer - Medical Devices
Posted on Sep 12, 2019 by Job Juncture
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.