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Human Factors and UX Design @ Ascensia
Responsible for conducting User Research, Feature Definition, UX Journeys, Prototyping, UI User Stories, Dev handoff and guidance, Usability, Formative and Summative Testing, and Post Market Surveillance in accordance with IEC and FDA standards and guidelines
NOTE: As most of this work is competitive and confidential, I cannot show the work publicly. Please contact me if you want to see more.
As the owner of the Human Factors/UX/Experience Design function, I am responsible for:
- Planning and executing all phases of qualitative research, from observational studies, on-body and in-person HF evaluations of physical systems, usability of digital interfaces, developing plans and protocols, and managing external UX validation vendors and facilities. (62366 4.1.1)
- Planning and executing Userface Evaluation Plan (R&D UX Plan) (IEC 62366* 5.7, 5.5, 5.7)
- Hosting stakeholder workshops to integrate real-world findings with internal expertise to stake out the landscape for the digital experience, reveal new insights to drive high value feature identification and design, identifying risks and risk controls (62366 4.1.1)
- Contributing to Medical Device Risk Analysis workflows and workshops to identify risks and risk controls (62366 4.1.2-3)
- Designing zero-fidelity to high fidelity prototypes
- Authoring, defending and evolving user facing Epics, Features, and User Stories.
- Provision of final design layouts, specifications, styles, and elements to Sprint teams within a just-in-time workflow.
- Dev handoffs and collaboration
- Code release micro-testing and usability testing
- Developing instructions for Use, QRGs, Illustrations and Infographics
- Formative and Summative Testing protocols, planning, vendor management, execution and documentation (62366 5.7-5.9)
- Post market vigilance surveillance: long term studies, analytics and other session analysis, and customer feedback through reviews, ratings, and customer service exchanges.
- Rinse and repeat
*IEC 62366-1 Edition 1.1 2020-06 Consolidated Version (2015-1 + A1 2020)
IEC TR 62366-2
FDA Applying Human Factors and Usability Engineering Guidance 2/3/2016
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