Conducting known problem analyses and risk analyses (uFMEA) for class II products

Defining user needs and product requirements for early-stage designs

Strategizing and executing on plans to complete summative validation for multiple projects

Completed phase 2 exit for a wearable medical device in development

Guided the Verily Retinal Camera project team through a successful summarize validation and FDA submission

• Planned and conducted formative usability studies to answer questions concerning risk and shape the user interface of products

• Conducted in-depth qualitative interviews with key user populations to develop personas, user needs, and an understanding of user behaviors

• Represent the user needs during the development of product design requirements and risk analyses

• Managed projects through summative usability studies to validate user safety prior to the start of clinical trials

• Conducted engineer design for manufacturability including injection molding, mechanical design, and more

• Developed and maintained medical device risk management programs

• Managed and sourced supplied goods and production processes

• Project managed medical device programs through FDA 510(K) submission process