Validation Engineer - Manufacturing Engineering
Cook Medical
Overview
The Validation Engineer performs and documents validations of medical device manufacturing processes.
Responsibilities
- 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations
Qualifications
- Bachelor's Degree in Engineering- 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 recommendations in writing.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
Requisition ID2025-16848
Posting Date22 hours ago(7/11/2025 7:44 PM)
Job Location(s)Bloomington IN United States
Job LocationsUS-IN-Bloomington
Position TypeFull Time
CompanyCook Inc - Bloomington
CategoryEngineering
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