Qualifications

• Expertise in user testing, evaluative research and presentation of actionable results to a varied audience
• 10+ years working with clinicians and medical personnel
• 10+ years in new product research, medical and consumer facing
• Extensive experience contracting, domestic and international
• Experience in mentorship, instruction and institutional best practices

Services: Creation and Review of Usability Engineering Files, Use Specifications, Task Analysis/URRA formative evaluations, HF validations (summative evaluations), HFE UE Summary reports, TRFs, HF Strategy

Research skills: requirements gathering, user-centered design methodology, software development lifecycle, in-person and remote formative usability studies, validation studies for medical device, qualitative data analysis, social media and recruitment experience.

Software: Microsoft Office Suite, Adobe Suite, Morae, Camstudio, OVO Logger 7.0, Agile CM, Salesforce 

Publications: Fonville, Choe, Oldham, Kientz,  Exploring the Use of Technology in Healthcare Spaces and its Impact on Empathic Communication. (pdf) – Truong, Kientz, Rosenzweig, Fonville, Smith, TCBI: The Design and Evaluation of a Task-Centered Battery Interface. (pdf)

EMRs: Cerner, Epic, Star  Standards:  IEC 62366 1/2

Seattle Human Factors LLC	July 2025 – present
Principal Consultant

• With over 10 years of regulated industry experience, I help companies complete the human factors deliverables necessary for 510k submission. Including task analysis, use specification, usability engineering file, HFE UE report, formative and summative evaluations. Other services include: expert heuristic analysis, Information for Use development and evaluation, gap analysis for audit preparedness, integration of market research with HF testing.

Natus Medical	March 2020 – July 2025
Lead Principal Human Factors Engineer

Projects: Algo Pro, NeuroWorks SleepWorks, BrainWatch, Camino

• Global lead and SME for human factors and usability engineering for Class I, II, III medical devices.
• Provide support for multiple projects in all stages of development, with a focus on standards compliance.
• Create updated Usability Engineering procedure with accompanying templates (Use Spec, Task Analysis, UEF, HF validation studies) to ensure company documentation is state of the art. Procedure and templates are now used throughout the organization.
• Perform task analyses, known use issue analyses, formative and validation studies as per FDA, IEC and Chinese NMPA guidelines.
• Provide guidance and training on human factors engineering to cross-functional employees.

Kestra Medical Technologies	April 2017 – March 2020
Senior Human Factors Engineer

ASSURE WCD System was recognized as the winner of the Bronze in the Cardiovascular Devices category, 2022 Medical Design Excellence Awards (MDEA).

• Responsible for user research, persona creation, task/hazard analysis, usability testing for wearable cardioverter defibrillators.
• Complete documentation in compliance with the FDA Human Factors Guidance and 62366- 1/2.

Independent Research Consultant	Sept 2016 – Mar 2017
Senior Human Factors Engineer

Stratos

• Perform research and consultation activities for Diabetes application tracking insulin injections with a focus on validation studies for FDA submission.

FUJIFILM SonoSite	May 2014 – June 2016
Senior Human Factors Engineer

Projects: X-Porte – SII – iViz ultrasound systems (SII Awarded the Silver at the 2016 IDSA International Design Excellence Awards)

• Design and perform formative and summative studies, iterative studies for quick feedback, early research for persona creation
• Act as a liaison to evangelize user research needs to product teams, communicate user experience strategy to the organization as a whole
• Complete all documentation necessary throughout the product lifecycle, support regulatory reviews of auditable materials
• Partner with design and engineering to create effective research activities to support multiple projects running in parallel

Microsoft MSN-Bing Apps	Mar 2013 – Mar 2014
Usability Researcher – Contract

Projects: MSN for Windows 8/IE 10 – Bing Finance App

• Usability and benchmarking studies for the Bing Finance app on the Surface and on the Windows phone. (Lab as well as remote)
• Perform in-person and remote usability studies using Agile methodology on MSN web/MSN phone, with rapid turnaround of results to team (3-4 days)
• Competitive analysis of international websites (30 in all) comparing MSN to its competitors across multiple business sectors, Automotive, Sports, Money, Entertainment and News
• Present feedback and recommendations to development, design and management

Cerner Corporation	Dec 2011 – Feb 2013
Usability Researcher

Projects: Lead Researcher for the PowerChart Touch™ iPad App (Awarded the Bronze at the 2013 UX Awards)

• Interact directly with end-users to gather data through usability testing methods as well as other user-centered design research techniques
• Create Usability Reports (in compliance with the ISO/IEC 25062:2006 and NISTIR 7742), Study Results Presentations and Validation Plans, make design recommendations based on observed user behavior and prior experience
• Present analysis of feedback and recommendations to stakeholders
• Conduct quantitative in-person and remote usability studies of iPad and desktop electronic health applications, approximately 5 participants per week over a 6 month project (using WebEx, Morae, Camtasia, etc.)
• Co-presenter at the 2012 Cerner Health Conference for the FetaLink+™ iPad app

Spacelabs Healthcare	May 2011 – Oct 2011
Usability Engineer – Contract

Projects: Aria Tele™ and Xprezzon™ telemetry monitors

• Design, administer and evaluate User Interface studies for software based medical equipment. This includes Beta testing of hand held telemetry units and bedside monitors
• Experience with Formative and Summative task-based UI testing in a R&D Validation Lab for design safety as mandated by regulatory standard IEC 62366-1
• Create Clinical Usability Reports, UI Test Summary, UI Test Result Presentations and other supporting documents for the Design Team
• Ability to interface with engineering, marketing, service and sales to enhance existing products while supporting new product development

Google	June 2010 – May 2011
Quality Assurance Specialist – Contract

The Map Project – The Germany Opt Out Project

• Track customer requests, evaluate priority, monitor request status, resolve customer concerns, and escalate  process bottlenecks
• Create documentation to continually update the workflow, bug reports, and software installation problems that arise
• Ability to work in an fast paced environment with rapidly changing requirements while still maintaining quality and project deadlines
• Performance tests of prototype software utilizing Black and Grey Box technique with Linux systems experience

Education

Master of Science in Information Management Focus on User Experience
University of Washington

NIH Course Completion: Protecting Human Research Participants – Member ID: 2262642

Usability Professionals’ Association – Member ID: 16780

Assisted in the invention of a Charger Cable Retention Clip – Ref: C00003645.S0