Overview


The primary purpose of this position is to design, test and technically document design changes required for the maintenance of released medical devices.


Responsibilities


- Serve as technical and project leader for product modifications involving design and/or process improvements- Consult with physicians and healthcare professionals to discuss validation test set-ups or to evaluate design changes- Provide support to regulatory department for product registrations with FDA and other global notified bodies- Develop and maintain Design History Files- Interface with production engineering and operations personnel to coordinate design and process changes- Work with suppliers to create or modify raw material specifications- Prototype devices and test fixtures to evaluate design and process changes- Interact with the machine shop personnel to develop tooling and equipment for use in production

- Must work and interact effectively...