Job Description

Title: Design Quality Engineer

Location: Plano, TX (only onsite, no remote)

Long Term Contract Role


JD (Updated):

  • 6+ years of Medical devices – Design / Development Quality experience on the projects related to Design Change, Clinical and New Product Development. New Product Development experience is a must.
  • Experience working on implantable Class III medical devices or safety critical embedded systems is a must.
  • Experience with software development life cycle (IEC 62304), verification/validation practices, and risk-based quality engineering.
  • Good experience in Medical devices regulations – ISO13485, FDA & EU MDR regulations
  • Experience in compiling Design history files & Technical file submission for 510k & CE mark
  • Own Risk Management files and ensure adherence to ISO 14971 – Risk management plan, Haz...

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