Kimberly VanCuren

Manager, Human Factors

Kimberly VanCuren has eighteen years of Human Factors engineering experience in large pharma and medical devices with a focus in Combination Products.  She has found tremendous success in being a critical utility player in the Human Factors space with managing documentation, supporting user requirements, providing design recommendations across product design and development lifecycle, customer requirements, systems validation summary reports, Hazard Analysis, related FMECAs, system validation summary reports, and usability validation summary reports. Kim has a long track record to integrate Human Factors processes while evaluated existing usability formative and summative study reports’ usability research methodology, number of intended users, and data collection.

Academic & Professional Qualifications:
  • CUA Certified, Human Factors International
  • Master of Science – Human Computer Interaction Design – Indiana University, October 2007 
  • Master of Science – Information and Communication Sciences (Network Eng.)  – Ball State Univ., Aug. 2003 
  • Bachelor of Arts – Telecommunications – Ball State University, December 1999 
  • Award – 2017 Star of Excellence Award, Medtronic Cardiac & Vascular
Training, Quality Systems, and Specialties:
  • Human Factors Analyses (e.g., Task Analysis)
  • Expert/Heuristic Design Review & Recommendations
  • Usability Testing
  • Usability Gap Assessments
  • EN ISO 11607-1:2020
  • BD EN 62366-1:2015 + A1:2020 standard
  • BS EN 60601-1-6:2010 + A1:2015 standard
  • EU MDR Human Factors Compliance 
  • Use Error Risk Analysis & Remediation