This role spans front-end innovation (ethnographic research, workflow analysis, opportunity framing, concept ideation, prototyping, and formative evaluation) and back-end validation (use-related risk analysis, labeling/UI development, clinical simulation, and summative/validation studies) to ensure products are safe, effective, and intuitive in complex clinical environments (OR/cath lab/ICU). The position partners closely with Systems Engineering, Design, Clinical, Marketing, Regulatory, Quality, and Software/Hardware teams to embed human factors and usability engineering into Design Controls and to meet FDA and global regulatory requirements (e.g., IEC 62366-1, ISO 14971).