Director of Human Factors

Position Summary:

We are seeking a Human Factors Engineer who will be responsible for ensuring that medical devices are safe, intuitive, and effective for intended users by applying human factors and usability engineering principles throughout the product lifecycle. This role plans and conducts formative and summative usability studies, develops use-related risk analyses, and ensures compliance with FDA, IEC 62366, and other applicable regulatory standards. The Human Factors Engineer collaborates closely with design, clinical, regulatory, and quality teams to identify, mitigate, and validate use-related hazards, ultimately supporting safe and effective patient and clinician experiences.

This role will work to develop and follow industry best practices defining and documenting usability formative studies, qualitative assessments, summative usability studies and preparing the Human Factors engineering usability file for regulatory submission. This role will report to the Vice President of Product Design.

Key Responsibilities:

• Drive discovery research with mix method data collection techniques.
• Implement usability rating system and testing protocol.
• Work with marketing and clinical teams to create user personas, use specifications, and user groups based on target markets and regulatory testing requirements.
• Develop protocols for formative usability studies.
• Collaborate with recruiters, IRB, and consultants for validation studies.
• Moderate and conduct online and in person testing of usability studies, as well as focus groups, and interviews.
• Maintain detailed video documentation to follow and support note taking.
• Present findings to designers, engineers, and management team.
• Facilitate and document task analysis, use related risk analysis, and user interface specifications.
• Maintain traceability of critical statements and risk mitigations from observation to Instructions for Use and device training.
• Maintain awareness of and share industry trends and platform best practices in human factors, usability and digital experience on iOS, Android, and web.
• Define, test and ensure that accessibilities standards for each platform are met.
• Track cultural differences and risks for items, terminology, and features.

Required Qualifications:

• The candidate must be familiar with Design Controls (21 CFR Part 820 / ISO 13485) and have experience maintaining the Design History File (DHF).
• Demonstrated success working in startup, early-stage, or high-growth medical device environments.
• Proven ability to build process from the ground up and adapt them as the organization scales.
• Comfortable operating with ambiguity and making sound decisions with incomplete information.
• Strong bias toward action, ownership, and continuous improvement.
• Bachelors, Master’s or PhD in Human Factors, ergonomics or related field.
• 5+ years of experience in human factors engineering.
• Proven success running usability studies for medical devices.
• Proven work examples or projects running usability testing for mobile devices (iOS, or Android).
• Excellent communication, collaboration, presentation, and interpersonal skills.
• Strong process orientation and documentation abilities.
• Understanding of best practices including accessibility standards and human factor standards.

Referred Attributes:

• Entrepreneurial mindset with a passion for building systems that enable teams to do their best work.
• Excellent communication, collaboration, presentation, and interpersonal skills.
• Strong process orientation and documentation abilities.
• Understanding of best practices including accessibility standards and human factor standards.

Additional Information:

Approximately 25-30% travel may be required.

Physical requirements/Work Environment:

This position is located onsite in Irvine, CA.

This position primarily works in an office. It requires frequent sitting, standing and walking. This position requires sitting for long periods of time in comparison of a computer display or other digital devices. Daily use of a computer and other computing and digital devices is required. May require standing for extended periods when facilitating meetings, walking in the facilities. Some travel may be required so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.