Quality Engineer (Usability Testing)

Denver, CO

Industry: Medical Device Job Number: 131992

 

Medical Device Quality Engineer (Usability Testing)

Environment:

Our client is a Medical Device manufacturer of primarily cardiac related devices. They are about to kick off a 30 participant clinician study either on site in Colorado or in a nearby location. They are seeking a Usability Engineer with experience in Quality/Regulatory, to take complete ownership of the study and ensure it is successful. The study is related to one of their most critical devices.

Scope of Work:

This project is critical for our clients primary device, a heating and cooling device used during cardiac surgery. This consultant should come from a Quality/Regulatory background in Medical Device and have experience with Usability Testing for Medical Device projects. This person will have most of the oversight for a 30 person clinician study. THey will be working with the Director of Engineering and a Project Manager in their R/D group to report the studies progress as the project goes on. This consultant should come from an Engineering background in Medical Device and be familiar with working with other engineers/testing for a usability study.This person will observe the study, on the floor, on a day to day basis and work closely with one usability engineer in the client' s Germany location.

This consultant should be familiar with Instructions for use, Usability study protocols, following proper procedures and ensuring the study does not deviate from their current protocols.

Required Experience:
  • Medical Device: 10+ years experience
  • Usability Engineering/Usability Testing for Medical Device
  • Quality/Regulatory
  • Quality Engineering
  • Quality Control
  • Excellent documentation and verbal skills

Desired:
  • Direct experience running a multi-participant engineering testing study for Medical Device clients

Job Type: Contract

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