Sustaining Engineer

Posting Date 4 weeks ago(9/2/2021 1:56 PM)
Requisition ID
2021-9489
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Engineering

Overview

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

Responsibilities

• 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.

Qualifications

• Bachelors Degree in Engineering 
• Previous project management experience preferred

• Knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving

• Knowledgeable with Windows based software (i.e. Word, Excel, Project, Power Point, Visio)

• 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.**

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