Post Market Engineer 2

Cook GroupWinston-Salem, NC
Hybrid

About The Position

The primary purpose of this position is to design, test and technically document design changes required for the maintenance of released medical devices.

Requirements

  • Bachelor's degree in Engineering or Engineering Technology or related discipline and minimum 3 years of prior relevant experience. Advanced degrees may reduce the experience requirement by 1-2 years.
  • Ability to work independently and remain self-motivated.
  • Proven problem solving skills.
  • Ability to travel up to 10% of the time.
  • Excellent written and verbal communication skills.
  • 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.

Responsibilities

  • Serve as technical and project leader for product modifications involving design and/or process improvements
  • Consult with physicians and healthcare professionals to discuss validation test set-ups or to evaluate design changes
  • Provide support to regulatory department for product registrations with FDA and other global notified bodies
  • Develop and maintain Design History Files
  • Interface with production engineering and operations personnel to coordinate design and process changes
  • Work with suppliers to create or modify raw material specifications
  • Prototype devices and test fixtures to evaluate design and process changes
  • Interact with the machine shop personnel to develop tooling and equipment for use in production
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization
  • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
  • Must strictly adhere to safety requirements
  • Maintain regular and punctual attendance
  • Must maintain company quality and quantity standards
  • Must have effective oral and written communication skills
  • Attend various trade shows to source raw materials or to attend Company exhibitions.
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