Work with me

I work at the intersection of human factors engineering and product management. I started my career in software testing at St. Jude Medical, moved into human factors because I was drawn to the human side of products, and have spent 21 years building that expertise across cardiac devices, patient monitoring, point-of-care diagnostics, and dialysis.

From deep HF engineering to curating great teams and end-to-end product leadership, I show up as a peer, not a vendor, and I know how to move fast inside a slow-moving industry. Let’s talk:

  • Designing and running formative and summative usability studies that hold up under FDA scrutiny

  • Translating clinical complexity and use error data into actionable requirements

  • Building Human Factors programs from scratch, including use-related risk analysis, task analysis, and summative validation

  • UX research that connects directly to product decisions

  • Cross-functional alignment across regulatory, clinical, commercial, and engineering

  • SaaS platform strategy in regulated, fleet-managed environments

  • Roadmaps and PRDs built for FDA and EU MDR submission readiness

  • Building product infrastructure from scratch, including backlogs, operating rhythms, and feedback loops

  • Mentorship and coaching for HF and product teams building their own capability

Human Factors & Usability

I plan and execute usability engineering programs that meet FDA and international regulatory requirements.

This includes user research, formative studies, use-related risk analysis, and summative validation. I help teams build HF programs from scratch or strengthen existing ones ahead of submission.

Product Leadership & Strategy

I help product teams translate user insight and clinical context into clear requirements and prioritized roadmaps.

I work as a fractional PM or strategic advisor for companies that need senior product leadership without a full-time hire.

Regulatory -Ready

I bridge the gap between design intent and regulatory documentation.

I help teams ensure their usability engineering files, use error analyses, and human factors reports are submission-ready for FDA and EU MDR.

Training & Coaching

I train product, engineering, and design teams in human factors methodology, usability study moderation, and regulatory compliance.

Available as workshops, team intensives, or ongoing coaching engagements.

Let’s talk.

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