Validation Engineer 1

The Validation Engineer performs and documents validations of medical device manufacturing processes.

- Validate and implement medical device manufacturing processes as assigned.
- Identify equipment/fixture installation qualification requirements.
- Characterization of processes and their outputs/acceptance criteria.
- Written preparation of applicable validation reports that meet regulatory/company standards.
- Verification testing
- Project management
- Maintain accurate and timely reports and records
- Must have excellent analytical and problem solving skills
- Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable.

- Bachelors 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.
- Minimum 3 years experience in medical device process development or process validation preferred
- Proficient in MS Office applications, especially Excel and Word.

Physical Requirements:
- Works under general office environmental conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
- Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.