Sr. Human Factors Engineer

Improve Patient Outcomes Through Innovative Healthcare Technology

Apply your Human Factors expertise to directly influence the next generation of healthcare technology. Join a collaborative team focused on developing innovative healthcare technologies, ensuring products are safe, effective, user-friendly, and compliant within a regulated environment. This remote position within the United States offers the opportunity to provide technical leadership throughout the product development process, contributing to usability engineering activities, supporting regulatory compliance, and identifying user needs and risks to deliver intuitive solutions that improve end-user outcomes.

Primary Responsibilities

• Author, review, and edit Human Factors engineering documentation related to assigned projects, including research protocols, research reports, Usability Engineering plans, Use-Related Risk Analyses, and other design control documentation.
• Support continuous improvement initiatives to strengthen Human Factors practices and documentation.
• Work cross-functionally with the core team to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
• Ensure the Human Factors Engineering process follows compliance within FDA recognized guidance and standards, including IEC-62366, HE75, and others.
• Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and validation of medical devices.
• Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
• Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices.
• Participate in the development of product requirements and the evaluation of risks related to product use.

Skills and Requirements

• Bachelor's Degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or a related discipline; Master's or Ph.D. degree preferred.
• 5+ years of work experience, including 3 or more years of relevant Human Factors engineering experience in the medical device industry.
• Deep expertise in effectively and efficiently documenting Human Factors Engineering deliverables in the medical devices industry.
• Demonstrated experience with use-related risk analyses on medical devices.
• Deep understanding of FDA's Human Factors Guidance and recognized standards (HE75, IEC-62366) related to medical devices, as well as theories, principles, and data associated with human performance capabilities and limitations.
• Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices.
• Experience with user-centered design methods.
• Experience with conducting formative and summative usability evaluations, including study moderation.
• Ability to direct and mentor junior staff.
• Background knowledge in diabetes and diabetes-care devices strongly preferred.
• Ability to self-motivate and self-manage.
• Excellent verbal and written technical communication skills.
• Ability to plan and conduct effective meetings and presentations.
• Ability to collaborate effectively in multi-disciplinary teams.
• Willingness to travel as needed (up to 25% of the time).

Compensation

$60.00 - $76.66/Hour