Usability Engineer

Responsibilities

• Develop and refine Use Specification, user profiles, and use environments.
• Conduct task analysis, identify potential use errors, and contribute to Use-Related Risk Analysis (URRA).
• Author formative usability study protocols, recruitment plans, moderator guides, and consent materials.
• Support logistics and execution of formative usability studies (remote and in-person).
• Conduct observation, data capture, coding of behaviors, and identification of use errors/close calls.
• Assist with preparation and execution support for summative (validation) studies.
• Produce HFE deliverables, including study reports, traceability tables, risk‑aligned mitigations, and documentation required for FDA submission.
• Collaborate closely with cross‑functional teams including design, engineering, systems, risk management, and clinical teams.
• Participate in UI evaluation, IFU review, labeling assessment, and identification of usability‑related risks.
• Travel (~25%) to usability labs, user homes, clinics, or internal facilities for product interaction and study execution.

• Strong knowledge of FDA HFE guidance for medical device submissions
• Familiarity with IEC 62366‑1, AAMI HE75, ISO 14971
• Ability to design, execute, analyze, and document usability studies
• Excellent observational and qualitative analysis skills
• Strong documentation and regulatory writing ability
• Comfortable handling early prototypes, hardware interfaces, and real‑use scenarios
• Ability to work independently while aligning with Philips HFE Lead direction

The candidate must be located in the United States

The candidate can work remotely. However, the candidate must be available to travel to conduct Usability studies and interact with the product up to 25% of their time.

Paid Leave, Health Insurance, Group life insurance, Disability, 401(K)

The expected salary range for this position is between $61,000 to $1,10,500 annually. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in role, base salary of internal peers, prior performance, business line, and geographic/office location.