Job Description

# Human Factors Engineer (Remote)

**Location:** Remote

## Position Summary

The Human Factors Engineer is responsible for conducting research to gain a deep understanding of users, product use, and use environments. This role performs task analyses, analyzes and characterizes use-related risks, and supports iterative formative evaluations and final usability validation of products prior to launch.

## Key Responsibilities

* Collect and synthesize detailed information on how users interact with products using techniques such as interviews, simulations, and task analysis.
* Present research findings and usability testing results to the New Product Development organization.
* Contribute to user interface design by providing guidance, ideas, and feedback to the product development team.
* Analyze complaints from on-market products to identify usability-related issues.
* Support the design, execution, and reporting of usability (human factors) tests throughout product development, from early prototypes to formal FDA-mandated validation testing.
* Collaborate with cross-functional teams to create and maintain usability risk analyses and user interface requirements.
* Maintain traceability between use-related risks, mitigations, and validation test cases.
* Stay current with regulations and industry best practices related to medical device human factors, including IEC 62366, AAMI HE75, and the FDA guidance *Applying Human Factors and Usability Engineering to Medical Devices*.

## Required Qualifications

* Bachelor's or Master's degree in Human Factors Engineering, Cognitive Psychology, Computer Science with a Human-Computer Interaction (HCI) emphasis, Human Centered Design, or a related field.
* 5+ years of relevant Human Factors experience in an industry setting.
* Superior ability to empathize with users and understand the human condition.
* Ability to interface with customers in a highly professional manner.
* Excellent verbal, written, and presentation communication skills.
* Strong analytical skills with the ability to synthesize large amounts of information into clear, actionable communications.
* Ability to collaborate effectively across engineering, product management, clinical engineering, regulatory, and other cross-functional teams.
* Demonstrated ability to apply user-centered design and usability engineering principles to product research, development, and design.
* Willingness and ability to travel domestically up to 25%.

## Preferred Qualifications

* Experience in the medical device industry or a similar regulated industry.

## Working Conditions

* None.

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