Principal Engineer

  • location: Saint Paul, MN
  • type: Contract
  • salary: $52 - $62 per hour
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job description

Principal Engineer

Principal Engineer needed in St Paul MN. This position is responsible for supporting the activities of a Design Owning Organization located in St. Paul, MN facility. The candidate will work with the St. Paul Product Design Owners (PDOs) in performing tasks related to regulatory compliance, change control, design control, and risk management. This is a contract position expected to last 12 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!

Responsibilities for the Principal Engineer

  • Support the PDOs in fulfilling requirements for regulatory compliance, design control and risk management activities for medical products.
  • Help ensure that design and development activities and documentation are within regulatory compliance, particularly for the new European Medical Device Regulation (MDR)
  • Help maintain the Design History Files and Risk Management files for medical products
  • Generate and manage work flow for appropriate change control documentation
  • Create and edit technical information, such as requirements, verification and validation protocols, and test methods
  • Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for design testing, risk analysis, change control, and regulatory submissions
Requirements for the Principal Engineer

  • BS degree
  • 7+ years experience in a medical or regulated industry
  • Design history file SME
  • Change Control experience (aka engineering change orders, change packages)
  • Experienced with all typical software tools (MS Office Suite, Minitab, CAD SW - prefer SolidWorks)
<Benefits for the Principal Engineer

  • Paid Vacation
  • 401K
  • Health Insurance, and more...
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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