Overview

Senior Human Factors Engineer opportunity to apply human factors expertise to the definition, design, evaluation, and validation of next-generation medical devices and systems.

Seeking an individual with proven human factors leadership in an FDA-regulated product development environment to join a small, dynamic team of human factors engineers and contribute to delivering a world-class user experience that enhances patient safety and clinician satisfaction.

Note

This position is eligible for hybrid working arrangements (on-site at least 1x/week; may work remotely other days).

Responsibilities

Author, review, and edit Human Factors engineering documentation related to assigned projects, including research protocols, research reports, Human Factors plans, and other design control documentation.
Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors.
Collaborate cross-functionally with the core team to ensure user interface requirements are met and risk controls related to patient use are applied and effective.
Ensure Insulet's Human Factors Engineering process complies with FDA guidance and standards (e.g., 62366, HE-75).
Analyze results from formative evaluations and make improvements based on Human Factors guidelines and best practices.
Provide research and design inputs related to human capabilities and product interactions to inform design, verification, and validation of medical devices.
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 or related discipline preferred.
Master's or Ph.D.

in Human Factors or Human-Computer Interaction preferred.

5+ years of work experience, including 3+ years in Human Factors engineering within the medical device industry (internships or graduate work included).

Preferred Skills And Competencies

Medical device industry experience required.
Deep understanding of FDA Human Factors standards (HE-75, 62366) related to medical devices.
Experience with user-centered design methods and conducting formative and summative usability evaluations, including facilitation in product development.
Solid understanding of perceptual, cognitive, motor, biomechanical, and anthropometric factors in human performance.
Ability to self-motivate, self-manage, and apply Human Factors principles to design, definition, evaluation, launch, and use of medical devices.
Ability to direct and mentor junior staff and contractors.
Excellent verbal and written technical communication skills; ability to plan and conduct effective meetings and presentations; collaboration in multi-disciplinary teams.

Physical Requirements

Willingness to travel as needed (approximately 25% of the time).

Additional Information

The US base salary range for this full-time position is $126,450.00 - $189,675.00.

Our salary ranges are determined by role, level, and location.

Details about specific salary range for a location provided during the hiring process.

Compensation details reflect base salary only and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ

PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.

For more information, please visit insulet.com and omnipod.com.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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Sr Human Factors Engineer Hybrid