Manager, Human Factors Engineering

Responsibilities

• Oversee a team of direct reports who author, review, and edit Human Factors engineering documentation related to assigned projects, ensuring the efficient delivery of high-quality documentation.
• Guide the creation and execution of formative and summative studies to support medical device design optimization to identify potential use errors.
• 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.
• Ensure Insulet’s Human Factors Engineering process is in compliance with FDA guidance and recognized standards including IEC 62366, HE75, and others.
• Oversee planning and delegation of Human Factors Engineering activities, aligning work with project timelines and regulatory requirements while monitoring team capacity to ensure workloads are balanced, achievable, and sustainably resourced.
• Ensure the daily function, motivation, and mentorship of a team of highly trained human factors engineers.
• Interview, train, and mentor new employees. Help employees set personal development goals as well as articulate to them both short and long-term company goals to ensure team work alignment.
• Guide the analysis of results from formative evaluations used to make recommendations for improvements based on Human Factors guidelines and best practices.
• 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.
• Leverage product development experience to provide strategic direction to the Human Factors team surrounding the deployment of resources across different pipeline projects, understanding the priority of projects is dynamic and shifts over time.

Requirements

Human Factors experience in the medical device industry required.

Deep understanding of Human Factors FDA guidance and recognized standards (HE75, IEC 62366) related to medical devices.

Prior industry experience with user-centered design methods and conducting formative and summative usability evaluations, including facilitation in support of product development.

Deep understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, biomechanical, and anthropometric).

Ability to self-motivate and self-manage as well as motivate and find appropriate challenges for a team of Human Factors Engineers.

Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices.

Ability to strategically direct and mentor junior staff members and contractors.

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).

Qualifications

Master’s or PhD degree in Human Factors, Human Computer Interaction, or related discipline.

7+ years of work experience including 5 or more years of relevant Human Factors engineering experience in the medical device industry (can include internship and/or graduate school experience).

3+ years of management experience.

Skills/Competencies

Human Factors experience in the medical device industry required.

Deep understanding of Human Factors FDA guidance and recognized standards (HE75, IEC 62366) related to medical devices.

Prior industry experience with user-centered design methods and conducting formative and summative usability evaluations, including facilitation in support of product development.

Deep understanding of the theories, principles, and data associated with human performance capabilities and limitations (perceptual, cognitive, motor, biomechanical, and anthropometric).

Ability to self-motivate and self-manage as well as motivate and find appropriate challenges for a team of Human Factors Engineers.

Ability to apply Human Factors principles and methods to the design, definition, evaluation, launch, and use of medical devices.

Ability to strategically direct and mentor junior staff members and contractors.

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).