The primary purpose of this position is to design, test and technically document design changes required for the maintenance of released medical devices.
- 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
- Minimum 4 year degree in Engineering/Technology.
- Ability to work independently and remain self-motivated.
- Proven problem solving skills.
- Ability to travel up to 10% of the time.
- Excellent written and verbal communication skills.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to supply sponsorship for employment visa status (e.g. H-1B or TN status) for this employment position.