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Design Quality Engineer

4 months ago

Santa Clara, United States Insight Global Full time

Title: Design Quality Engineers



Location: Onsite in Santa Clara, CA



Duration: On going Contract - potential to go perm




Must Haves:

  • 5+ years of experience within a med-device environment
  • Design quality engineering (NPD, Verification, Validation, etc.)
  • New Product Development experience
  • Class 2 electrical-mechanical systems per IEC 60601
  • Risk management process per ISO 14971




Plusses:

  • Jira/Agile PLM
  • GD&T knowledge
  • FDA requirements for design control of medical devices
  • Minitab for statistical analysis
  • Slack
  • Start-up company experience




Day to Day:

Insight Global is searching for a couple of Design Quality Engineering resources who will be sitting onsite, working for one of our local Santa Clara Med-Device clients. They will be supporting the new product team for new product development for a robotic surgical device. This resource will be supporting review of design verification related deliverables for the program. They will be designing verification protocols and summary reports, performing test method validations, test fixture design review and qualifications, and reviewing regression analysis to ensure impacts are clearly justified. They will be supporting installation qualification of non-product software and test equipment, and supporting risk management activities of dFMEA for the sub-systems. They will be cross-functionally collaborating on key quality processes such as defect tracking/resolution, test execution, etc. They will support review of build protocol / build report, DHR and configuration change and its impact on Design Verification reports. They’ll review design changes including mechanical and electrical drawings, support creation and review of Inspection plan for components and sub-assemblies. They will support review of design control deliverables. This is a contract extending through the end of 2024, and will be eligible for long-term extensions through 2025 as this project is expected to continue long-term. Our contractors are eligible for conversion to FTE at any time, upon client’s positive performance.