Must have BSME, MSME preferred. Plastics engineering degree considered.
Plastics knowledge with engineering grade resins a must
More than 15 years experience
Must have medical device experience, disposables preferred.
familiar with ISO13485 and 14971
Must have experience with process capability and SPC
knowledge of manufacturing processes such as plastic injection molding, ultrasonic welding, etc.
Must be willing to be hands on and wear multiple "hats". -be ready to participate in quality systems, engineering, mfg, regulatory activities, etc.
Individual would be a motivated, self-starter who handles multiple projects at the same time.
willing to work, and thrive in a security conscious environment.
Must self-manage projects and documentation.