Job Description

Human Factors Engineer

Position Overview: The Human Factors team is looking for an enthusiastic and team-focused Senior Human Factors Engineer that has a desire to apply Human Factors principles to design safe, effective and usable products for the diabetes-care industry. We have an exciting opportunity for an exceptional Senior Human Factors Engineer to apply his/her human factors expertise to the definition, design, evaluation, and validation of next-generation medical devices and systems. We are seeking an individual with proven Human Factors leadership and skills in the regulated environment of medical device product development. You will be joining a small, dynamic team of human factors engineers to contribute to the design and development of innovative, next-generation medical devices. The ideal candidate should be someone who is highly experienced with deep domain knowledge in Human Factors, thrives in highly collaborative environments, is an analytical thinker, has a high level of curiosity for problem solving, and wants to make a direct impact on patient lives by ensuring the products they use achieve world-class safety and usability. This position is remote within the United States.

Responsibilities: Author, review, and edit Human Factors engineering documentation related to assigned projects. This includes 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 Human Factors Engineering process is in compliance with 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 the 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 evaluation of risks related to product use (risk analysis)

Education and Experience: Bachelor's Degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or 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 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).

Skills/Competencies: 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 Background knowledge in diabetes and diabetes-care devices strongly preferred 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

Job Tags

Similar Jobs