The primary purpose of this position is to provide technical support to the production area by validating, facilitating, testing and technically documenting the feasibility of device construction and processing as it relates to new and/or changed production.
- Perform IQ, OQ, PQ and TMV for processes in manufacturing.
- Monitor Validation processes with manufacturing.
- Improve and implement new processes into production concerning existing product lines.
- Assist in the transition of product modification from product development into the production environment.
- Facilitate building and testing new process prototypes.
- Assist during pre-production run of new products.
- Maintain complete accurate documentation related to product assessment or improvements.
- Attend trade shows to source raw materials and equipment.
- Develop software plans for new and existing equipment.
- Formulate manufacturing costs for process changes based on labor, equipment acquisitions and raw material rates.
- Bachelor’s degree in Engineering/Technology.
- Experience and understanding of the equipment validation process (Test Method Validation, Process Validation).
- Prior medical field experience preferred.
Equal Opportunity Employer
Qualified candidates must be legally authorized to be employed in the United States. COOK does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.