Manufacturing Engineer (Design Control)

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Manufacturing Engineer (Design Control)

  • Specialty:

    Engineering
  • Title:

    Manufacturing Engineer (Design Control)
    • City:

      Lawrenceville
    • State:

      GA
    • Zip Code:

      30043
  • Start date:

    12-08-2016
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    45179

Description

Manufacturing Engineer
Our client is currently seeking candidates for the position of Manufacturing Engineer in Atlanta, Georgia. The Manufacturing Engineer will support documentation on existing products, coordinating with contract manufacturing partners.  Projects will be driven by revisions to existing product lines and will include design control documentation, risk management documentation, and new equipment validation.
 
Requirements:
  • Project Management:  Lead and manage projects with discipline, accountability, and collaboration
  • Support documentation on existing products, coordinating with contract manufacturing partners.  
  • Projects will be driven by revisions to existing product lines and will include design control documentation, risk management documentation, and new equipment validation.    
  • Collaborating with a network of contract medical device manufacturers
  • Facilitate a gated development process and associated decision-making and detailed documentation 
  • write and implement comprehensive verification and validation plans
  • Develop protocols and coordination with 3rd party testing labs
 
Qualifications:
  • Project Management:  Lead and manage projects with discipline, accountability, and collaboration
  • 5 - 10 years engineering and manufacturing experience in medical device, specifically experience in FDA CFR 820 and ISO 13485 regulated environments
  • Experience working within regulations of ISO13485, FDA, and CE compliance. Ideally, recent training in ISO13485-2016
  • 3rd Party Manufacturing: Experience – collaborating with a network of contract medical device manufacturers
  • Experience working with design control documentation and risk management documentation
  • Engineering Degree required
  • EO Sterilization experience a strong plus

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