Job Description

Job Title

Human Factors Engineer

Location

Remote

Description

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.

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

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