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Cook Medical Process Validation Engineer in Bloomington, Indiana

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

  • 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.- 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.

**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.

Posting Date2 weeks ago(4/7/2021 11:08 PM)

Requisition ID 2021-8740

Job Location(s) Bloomington IN United States

Shift Type First

Position Type Full Time

Company Cook Inc.

Category Engineering

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