Human Factors Engineer
Contract · Remote · Medical Device
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| Position | Human Factors Engineer |
| Engagement | Contract |
| Location | Remote |
| Eligible Locations | United States |
| Travel | One trip — 6 days onsite in South Florida for summative testing |
| Hours | Flexibility to work 6:00 AM – 3:00 PM EST |
| Start Date | On or before September 1 |
| Interviews | Beginning as early as next week |
Position Summary
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 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.
Key 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.
Required Qualifications
- 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.
PandoLogic. Keywords: Ergonomist, Location: Miami, FL - 33134