Cook Polymer Technology needs a Validation Engineer to perform and document validations of medical device manufacturing processes, ensuring the ongoing validated state of these processes and supporting quality improvement and development efforts.
Requirements
- Minimum 3 years experience in medical device process development or process validation, understanding of processing principles.
- Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing.
Responsibilities
- Performs and documents validations of medical device manufacturing processes.
- Provides technical support for the day-to-day production activities, engineering activities, and quality activities.
- Helps support and facilitate quality improvement efforts, manufacturing changes, process and product development, process risk management, and execution of validation activities.
Other
- Bachelor's Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field; or experience of such kind and amount as to provide a comparable background.
- Project management, team management, and leadership skills to help coordinate efforts in maintaining the validated state of the processes.
