Sustaining Engineer at Cook Inc.

Posted in General Business 4 days ago.

Type: Full-Time
Location: Spencer, Indiana

Job Description:

Sustaining Engineer

Posting Date 5 days ago (9/13/2021 10:35 PM)

Requisition ID 2021-9528 Job Location(s) Spencer IN United States Shift Type First Position Type Full Time Company Cook Inc. Category Engineering


The Sustaining Engineer at Cook Inc. will lead product and process remediation efforts, in addition to performing sustaining activities for commercially available products.


• Interface with Contract Engineers, Development Engineering, Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians as necessary to progress projects/tasks
• Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals
• Analyze risk using CEA and current FMEAs
• Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable
• Identify user needs and develop into design input requirements
• Formulate Verification & Validation Test Plan and collaborating with other COOK departments to execute testing

• Update device and production specifications accordingly
• May supervise / coach technicians or other engineering employees

- 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
minimal supervision.
- Ability to remain calm and receptive in fast paced situations.


- Bachelors Degree in Biomedical or Mechanical Engineering
- Previous project management experience preferred.
- Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving.
- Proficient in Microsoft Word/Excel/Outlook.

Physical Requirements:

- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.

- 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.


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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.

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