The Sr. 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.
- 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.
- Bachelor's degree in Engineering or Engineering Technology or related discipline.
- Minimum 5 years engineering experience in a regulated industry, preferably in a medical manufacturing environment; 7 years preferred.
- Experience using analytical skills and problem solving.
- Experience in communication and working with a wide variety of associates.
- Experience working independently and directing others towards a common goal.
- Proficient in Microsoft Word/Excel/Project/Outlook, JBase, Livelink, Engineering Server, Business Objects.
- 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) of this employment position.**