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
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
- Must strictly adhere to safety requirements.
- Maintain regular and punctual attendance.
- Must maintain company quality and quantity standards.
- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with
- Ability to remain calm and receptive in fast paced situations.
- Bachelors Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field
- Minimum 3 years experience in medical device process development or process validation.
- Proficient in MS Office applications, especially Excel and Word.
- 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.
**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.