Human Factors Engineer

Job Description:
Human Factors Engineer
Must be local to Acton, MA or San Diego, CA

The *** Human Factors team is looking for an enthusiastic and team-focused Human Factors Engineer that has a desire to learn and apply Human Factors principles to design safe, effective and usable products for the diabetes-care industry.
The Human Factors Engineer will be integral to the completion of Human Factors deliverables needed for the definition, design, and evaluation of medical devices within the diabetes-care industry. In this role, you will be joining a small, dynamic team of Human Factors Engineers to contribute to the design and development of next-generation diabetes products prior to commercial release. The ideal candidate is someone who has experience in Human Factors, thrives in highly collaborative environments, is an analytical thinker, has a high level of curiosity when solving problems, and wants to make a direct impact on patient lives by ensuring the products they use achieve world-class safety and usability.

Responsibilities:
·Will author, review, and edit Human Factors engineering documentation related to assigned projects. Examples of documentation include:
o Formative protocols and reports
o Validation protocols and reports
o Usability Plans
o Use Specifications
o User Interface Specifications
o Use Related Risk Analyses
·Plan, execute, and report on Human Factors formative and validation studies to support medical device design optimization.
·Perform root cause analyses and other qualitative data analysis methods to analyze data from Human Factors formative and validation studies. Based on study results, provide actionable design recommendations, and create presentations summarizing study results.
·Work cross functionally within product core teams to ensure use-related risks have been comprehensively evaluated and that appropriate risk controls are in place to ensure safe and effective use.
·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.
·Support continuous improvement initiatives to strengthen team practices and documentation.

Education and Experience:
Minimum Requirements:
·Bachelor’s degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or related discipline.
·Master’s degree in Human Factors, Human Computer Interaction, Cognitive Science, Biomedical Engineering, or related discipline preferred.
·1-3 years of relevant work experience, Human Factors engineering experience in the medical device industry 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 to a location within the United States as needed to support formative and validation studies (up to 25% of the time).

Preferred Skills/Competencies:
·Working knowledge of FDA’s Human Factors Guidance and recognized standards (HE75, IEC 62366) related to medical devices.
·Experience with user-centered design methods.
·Experience conducting Human Factors formative and validation studies, including study moderation.
·Understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, biomechanical, and anthropometric).
·Ability to apply Human Factors principles and methods to the design, definition, evaluation, and use of medical devices.

Start Date - End Date: May 11, 2026 –May 7, 2027