User interface design and usability engineering for medical devices and combination products (UX/UI for SaMD, SiMD, hardware)

Technical Subject Matter Expert (62366, 14971, 21 CFR, HE75) • HFE documentation analyses, gap analyses, and strategic guidance to address FDA-cited deficiencies and optimize HF documentation for CDRH and CDER FDA submissions (formative and HF validation protocols and reports, data, HFE/UE Summary Reports) • Author Task Analyses, uFMEA, Design Input Requirements, HFE/UE Summary Reports, Traceability Matrices, residual risk analyses, etc. to support regulatory pathwayInstructional Design / Labeling Development (IFU, PI, Quick Start Guide) • Heuristic analyses and strategic guidance on system labeling and primary and secondary packaging • Author text and illustrations, prototypes, production artworkTechnical Project Management • Author and manage scope, budget, schedule, risks, deliverables, project charters, rosters, project plans

AI machine learning, Software as med device (SaMD), IEC 62366, agile, Azure DevOpsUX/UI design development, design language application and development, FigmaRadiology, PACS

Commercial Core Content Lead for Amgen platform devices o Developed promotional injection educational content for patients, caregivers and HCPs o Improved patient and HCP training, PSP processes and field force alignment o Developed and implemented action plans to reduce product complaints and improve patient experience

• Commercial platform device strategy and requirements• Drug delivery LCM opportunities, patient and HCP cocreation, concept development• Patient journey work informing marketing strategies for early assets development• Patient injection experience assessment and opportunities, service blueprint, business recommendations

• Account management, program development and management, new business development• Design leadership, internal and external project team management• Develop and maintain schedules and budgets, run multiple interdependent projects in concert, manage resources and risks• Plan and execute formative HF usability studies, qualitative market and ethnography research, cocreation• Seek and interview new hires

• Create brand strategies, product platforms, and visual design language systems• Lead ideation sessions, brainstorms, co-creation workshops with cross-functional teams• Design, plan, manage fabrication of functional prototypes for user evaluation and performance testing• Develop device user interfaces, graphics, IFUs, HCP demo kits• Author requirements documentation

• Design development of medical and consumer products• Conduct user research and translate insights into design requirements and opportunities• Create interactive UI mockups and interactive multi-media presentations • Market segment development and profiling, market analysis and trend forecasting• Leverage human factors (HE75) and anthropometric data, conduct ergonomic analysis to inform design development and engineering