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Sustaining Engineer
Sustaining EngineerCook Medical • Indiana, PA, US
Sustaining Engineer

Sustaining Engineer

Cook Medical • Indiana, PA, US
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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

Qualifications

  • Bachelors Degree in Engineering or Engineering Technology, or experience of such kind and amount as to provide a comparable background
  • 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)
  • 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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    Sustaining Engineer • Indiana, PA, US

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