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Sr. Manufacturing Engineer

Job Post Index 229DCE-Sy##
Location Minnetonka, MN
Description: Job Description
  • Device records and device compliance for EUMDR
  • Working in manufacturing environment
  • Take an effective and proactive leadership role in a specific technical manufacturing discipline.
  • Set direction for, lead, and take ownership of complex manufacturing engineering technical tasks that may have multiple inter-coordinating elements.
  • Anticipate and identify key issues and make recommendations for resolution where precedent may not exist and creative thinking is required.
  • Resolution may involve the application of new methods and approaches and may require the consideration of impact with other system components.
  • Interaction with peers and mentors on the individual's projects is generally in the context of peer review to confirm the rationale for task approach direction and peer review of verification/validation activities.
Skills: Qualifications
  • Bachelors of Science or Bachelors of Engineering in Electrical, Software, or Mechanical Engineering.
  • A minimum of 6 years experience in an engineering discipline or advanced education to achieve the level of skill.
  • Demonstrated EU-MDR experience
  • Ability to work with a cross functional team
  • Conformable with documentation work
  • Ability to work with teams
  • Process validation skills
  • Familiar with IQ/OQ/PQ
  • Medical device experience required
  • 2-3 years of experience with EUMDR or Medical device and process validation experience

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