Wendy Yee

About Wendy Yee

Rigorous SW design controls and SW validation for IVD and Class medical devices: 10+ years leading and building software-focused Design History Files for diagnostic medical devices. Certified ISO 13485:2016 Lead Auditor (TPECS). Experienced in MDSAP, PAI, and BIMO audits. Extensive experience with FDA requirements for Class software (NGS pipeline, lab automation, CSV), SW risk controls, cybersecurity, interoperability, human factors, change controls, and deploying IVD software in CLIA environments. Skilled in medical device hazard and risk analyses, mitigations through design, and coaching stakeholders on design controls and software validation.

Experience

1. Sr Director, Software Product Management

   Natera

   Mar 2026 — Present

Education

• Massachusetts Institute of Technology

  Bachelor of Science, Brain and Cognitive Science

• The Johns Hopkins University School of Medicine

  Ph.D., Neuroscience

Skills

• User-Centered Design
• Usability Testing
• User Experience
• Information Architecture
• User Research
• Interaction Design
• User Interface Design
• Human Factors
• Human Computer Interaction
• User Interface
• User Experience Design
• Usability
• Usability Engineering
• Medical Devices
• Heuristic Evaluation
• Qualitative Research
• Product Design
• Rapid Prototyping
• Contextual Inquiry
• Mobile Devices
• User Scenarios
• Product Development
• Task Analysis
• Experience Design
• Persona
• Prototyping
• Prototype
• Paper Prototyping
• Human-Computer Interaction
• Medical Diagnostics
• Defining Product Requirements
• Field Research
• New Product Validation
• User Requirements
• Project Management
• Wireframes
• Agile Methodologies