Job Description

"We have a need for someone with a background in compliance testing. An ideal candidate would have a background with 60601 testing for the FDA. This would include EMC emissions and immunity as well as safety testing for medical devices."

Compliance engineer to 
  • Help drive 60601 compliance effort
  • Background / experience in 60601, including things like:
  • Creating / updating compliance, safety, and EMC test plans
  • Index items in the risk management file
  • Compile and index design documents to support safety reviews
  • Provide primary point of contact to the test lab, helping to schedule testing and reviews, routing feedback appropriately, etc.
  • Pull together feedback from expert 60601 consultancy and incorporate those inputs into the larger effort and keep everything coordinated
  • EMC mitigation design expertise would be helpful as well, but less critical

"I can tell you that we need to do a few rounds of prescreen testing at UL here in Raleigh sometime in the early June and Late July time frames. We will also be conducting a comprehensive compliance test run in the late August time frame. A fair amount of work must happen between now and the full formal run and in my experience these things tend to go beyond schedule with retesting and R&D.
This role may involve travel to test houses that are out of state."

Application Instructions

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