Human Factors Engineer

About the role

Our client — a global leader in medical devices — is adding a Human Factors Engineer to support usability engineering across an active product program. This is a hands-on contract role owning formative and summative evaluation work and the documentation that supports regulatory submission. The position is remote with a single onsite travel commitment for summative testing.

Responsibilities

• Execute human factors and usability engineering activities in accordance with IEC 62366 across Class II and Class III medical devices.
• Develop and maintain use-related risk analysis (uFMEA) to drive formative evaluation planning.
• Plan, run, and analyze formative evaluations; support summative validation testing onsite.
• Author and support human factors documentation and deliverables in support of 510(k) submission.
• Partner with cross-functional engineering teams across both software and hardware elements of the system.
• Communicate findings and design recommendations clearly to engineering, quality, and regulatory stakeholders.

Requirements

• Direct human factors experience with medical devices, Class II and Class III.
• Working knowledge and applied use of IEC 62366.
• Experience building uFMEAs, running formative evaluations, executing summative testing, and producing the required documentation.
• Human factors experience supporting 510(k) submissions.
• Experience across both software and hardware.
• Strong written and verbal communication skills.
• Availability for a 6-day onsite summative testing trip.

Preferred Qualifications

• Advanced degree in Human Factors (MS or PhD).
• Experience working within interdisciplinary teams (systems, chemical, software).
• Background in robotics, surgical robotics, navigation systems, or spine.

Schedule

• Flexibility to work 6:00 AM – 3:00 PM EST.
• Start date on or before September 1.
• One trip — 6 days onsite in South Florida for summative testing.

Interviews beginning as early as next week.