Medical Device R&D Quality Engineer

Denver, CO

Job ID: 125114 Industry: Med

 

Medical Device R&D Quality Engineer

Environment:

Our client is a large medical device manufacturer. They develop and manufacture a number of cardiac medical devices. They are looking a quality engineer to come in and support day to day business while the client works through a small remediation.

Scope of Work:

Client is looking for a Sr. R&D Engineer with extensive experience dealing with technical challenges effectively and efficiently through use of problem solving tools and techniques, including planning and executing robust designs of experiments, root cause investigations, objective analysis, logical conclusions and quick follow through. This is very data driven problem solving.

There will also be documentation activities within CAPA, change management, and document control systems; documentation output stands on its own, reflects sound engineering, and is well supported. Thorough review of legacy product design input / design output traceability matrices, including identification and closure of remediation activities. This person will also be responsible for performing frequent design reviews, aligning with peers, incorporating actions and feedback into ongoing work, adjusting course as necessary. Must have experience with design controls, risk management for medical devices and an extremely strong background statistical analysis and tools (JMP or Minitab software) is required.

Required Experience:
  • Medical Device: 7-10+ years
  • R&D Engineering
  • Design Controls
  • Risk Management
  • Statistical Analysis
  • Root Cause Investigations

Job Type: Contract  

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