Design Assurance Engineer

  • location: Osseo, MN
  • type: Contract
  • salary: $37 - $53.82 per hour
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job description

Design Assurance Engineer

job summary:
A Design Assurance Engineer is needed for a leader in electronics, healthcare, and lighting in the Maple Grove, MN area. In this role, you will have the opportunity to support the transfer of Design Controls from a recent acquisition. You will be leading the remediation activity for risk management and supporting other transfer activities associated with the DHF transfer.

location: Maple Grove, Minnesota
job type: Contract
salary: $37.00 - 53.82 per hour
work hours: 8am to 5pm
education: Bachelors
  • Leading the Risk Management File Remediation activities.
  • This will include creation of new: Risk Management Plan, Product Hazard Analysis, Use FMEA, Design FMEA, Process FMEA, Risk Management Matrix, Risk Benefit Determination, Risk Management Report.
  • Understanding the processes and intent of all aspects of the QMS related to Design Controls.
  • Work with product development and sustaining teams and other Design Assurance QEs to assure compliance to the QMS.
  • B.S. degree in Mechanical Engineering, Biomedical Engineering or related Science discipline.
  • 2+ years' experience in Design Quality, Product Development or Operations Quality.
  • 2+ years' experience in medical device industry.
  • Working knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971, IEC62304).
  • Working knowledge of the new product design and development in a regulated environment; preferably medical device.
  • Working knowledge of the application of risk management; preferably to medical device development.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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