Principal Engineer, Human-Centered Design

- Lead ethnographic research, contextual inquiries, and observations in OR/ICU to gather voice of the customer insights, create journey maps, workflows, and identify unmet needs to inform actionable product specifications in collaboration with Marketing and R&D. - Oversee human factors engineering efforts, including formative usability studies and summative validation, developing user profiles, task analyses, use specifications, and use-related risk analyses (URRA/UFMEA) across various projects. - Offer expert advice on HFE strategies, assess and approve HFE documentation, and collaborate with Regulatory teams to maintain compliance with IEC 62366-1 and FDA Human Factors standards. - Convert user requirements into comprehensive specifications, interaction guidelines, and design principles, working across UX/UI, Industrial Design, Systems Engineering, and R&D to establish safe and intuitive workflows. - Assist in low- to high-fidelity prototyping and simulation evaluations, impacting early-stage concept development and the identification of strategic opportunities. - Act as the human-centered design authority across several initiatives, defining design strategies at the portfolio and platform level while leading cross-functional workshops, design sprints, and collaborative brainstorming sessions. - Mentor engineers and designers on research methodologies, synthesis, human-factors regulatory pathways, and design strategies; work with upstream marketing to clarify problem spaces and future program need statements. - Manage key Human Factors Engineering deliverables, including HFE plans, research protocols, usability reports, and traceability matrices, while contributing to Design History File (DHF) inputs and risk management documentation.