Capabilities & Impact

Built and led high-performing design teams across industrial and UX disciplines, supporting FDA-cleared diagnostic and therapeutic products
Mentored designers through full product lifecycles, from concept to commercial launch
Established career development frameworks, performance reviews, and hiring practices
Fostered design culture within engineering-led organizations through cross-functional alignment and advocacy.

Led the industrial design of complex systems, handheld instruments, and disposables
Developed product design languages that strengthen brand identity and improve manufacturing efficiency
Collaborated with ME and manufacturing to ensure DFM/DFA compliance, reduce part count, and optimize assembly
Delivered products that won numerous design and product awards.

Framed early product vision and business alignment through strategic storytelling, journey maps, and concept workshops
Facilitated design sprints and KOL sessions to align user needs with business and engineering constraints
Developed design strategies that translated to commercially viable, highly differentiated designs

Acted as design lead and strategic contributor within product core teams (engineering, marketing, clinical, QA/RA, operations)
Presented product vision and design direction in executive design reviews and board meetings
Championed the role of design across functions—ensuring usability, feasibility, and viability are in balance
Helped drive 510(k) submissions and verification/validation documentation

Led comprehensive HF programs including formative and summative usability studies, contextual inquiry, heuristic evaluation, task analysis, and preference testing
Authored and executed FDA-compliant usability protocols; managed participant recruitment, IRB interface, session moderation, data analysis, and reporting
Interpreted behavioral data and usability metrics to guide design updates, mitigate risk, and support 510(k) submissions
Translated IEC 62366-1 and FDA guidance into actionable requirements across hardware, software, labeling, and training materials
Delivered compliant, user-validated IFUs and user manuals, quick start guides, and UI copy, aligned with FDA, ISO, and risk control objectives
Oversaw HF consultants and third-party researchers, guiding protocol fidelity, study execution, and reporting quality
Partnered with RA/QA to finalize HFE/UE documentation and DHF deliverables for regulatory submission

20+ global design awards (IDEA, Red Dot, Edison, MDEA, Core77, R&D 100, UX Design)
15+ named design patents across diagnostics, therapeutics, and digital health
Reduced onboarding time by 40% at clinical sites through multimedia training and usability refinement
Achieved <5% residual use-related risk in summative testing across >150 users
Authored FDA-aligned protocols and HF validation reports supporting 510(k) submission
Improved on-time design deliverables through agile planning and structured HF milestone tracking
Drove design and human factors strategy for TriVerity IVD platform (Red Dot & UX Design Award, 2024)