Principal Human Factors Engineer

Abbott seeks a Principal Human Factors Engineer to lead human-centered design strategy across physician-facing medical devices and patient-facing consumer health solutions. The role combines clinical safety, usability research, and regulatory expertise to optimize experiences across the product lifecycle from concept through commercialization.

Responsibilities

• Define and execute human factors vision and strategy across physician and patient-facing medical technologies
• Lead usability engineering activities, use-related risk analyses, and regulatory submissions per FDA and international standards
• Design and conduct formative and summative usability studies with physicians, patients, and consumers across diverse health literacy levels
• Model and optimize end-to-end clinical and home environment workflows to reduce cognitive load and safety risks
• Mentor design, engineering, and research teams on human-centered design principles and regulatory compliance expectations

Requirements

• Bachelor's or Master's degree in Human Factors, HCI, Biomedical Engineering, Psychology, or related field
• 8+ years human factors or usability engineering in regulated medical device or digital health environments
• Deep knowledge of FDA Human Factors Guidance, IEC 62366, ISO 14971, and AAMI HE75 standards
• Proven ability to conduct user research with healthcare professionals and patients using mixed-method approaches
• Demonstrated experience influencing product strategy and executive decision-making as a principal contributor
• Strong skills in usability validation, risk analysis, and regulatory documentation preparation
• Excellent communication and presentation skills for cross-functional team engagement