Design Quality Engineer (IVD/Diagnostic)

Seattle, WA

Industry: Medical Device Job Number: 133976

 

  Design Quality Engineer (IVD/Diagnostic)

Environment:

Our client is a manufacturer of Diagnostic devices. They are currently in need of Design Quality Engineering support to assist their product development teams.

Responsibilities:

This individual will come from a background in IVD/Diagnostics or Medical Device engineering. They should be well versed in Quality Engineering, particularly from a Design perspective. They will work closely with the company' s new product development teams to provide DQE, Quality Compliance and functional quality guidance/support. This person will be required to read and understand NPD documentation, ensure proper V/V documentation is in place and ultimately ensure they are building the products they intend to- with quality ensured. There will be documentation involved for the NPD efforts, so someone who is well written and well spoken is preferred. This individual should be prepared to think at a strategic level and help provide guidance to NPD teams that lack experience or knowledge in Design Quality. This role is not meant for someone with a solely Manufacturing background/mindset- the devices this organization create contain analytical components that require an understanding of IVD/Diagnostics (preferable).

Required:
  • IVD/Diagnostic/Medical Device 5-7 years of experience
  • Design Quality Engineering
  • NPD/ R&D Documentation experience

Huge Plus:
  • Understanding of Analytical Assay Development
  • Understanding of instrumentation platform development
  • Degree in Biology, Chemistry, Bio-engineering, Life-sciences fields, etc.

Job Type: Contract 

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