Design Assurance Engineer

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Design Assurance Engineer

  • Specialty:

  • Title:

    Design Assurance Engineer
    • City:

      St. Paul
    • State:

    • Zip Code:

  • Start date:

  • Status:

  • Assignment Type:

    Direct Hire
  • Job Id:



DAVIS Companies has partnered with a leading Medical Device Manufacturing company to identify a Design Assurance Engineer to join their growing team! Local candidates only please. 

Essential Duties and Responsibilities of the Design Assurance Engineer: 

  • Execute and support on-time completion of Design Control Deliverables
  •  Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
  • Support internal & external audit responses
  • Support product re-certifications
  • Lead or support execution of biocompatibility and sterilization qualifications
  • Lead or support Risk Management activities
  • Define and implement Verification and Validation activities
  • Facilitate project plans and reviews
  • Write/update manufacturing work instructions as needed
  • Process document change orders (DCO’s) promptly, accurately and completely
  • Develop processes that are safe, mistake proofed, and easy to follow instructions using design for manufacturing principles

Desired Experience & Education of the Design Assurance Engineer: 

  • Bachelor’s Degree in Manufacturing Engineering OR equivalent
  • 5-8 years of Medical Device experience
  • Software proficiency: Microsoft Word, Excel, PowerPoint, Project, Solidworks, Minitab
  • Manufacturing process knowledge including: Lean Manufacturing, Packaging, Labeling and Clean room and sterilization processes
  • Experience with small to large semi-automated equipment implementation including: Working with outside equipment manufacturers for quotes, Design inputs/outputs and Validations (FAT, SAT, IQ, OQ, PQ)
  • Materials selection knowledge including physical properties and biocompatibility
  • Good understanding and working knowledge of FDA medical device regulations, ISO 13485, Health Canada medical device regulations, European medical device regulations, ISO 14971



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