Senior Human Factors Engineer — Medical Devices Usability Lead

Kaleidoscope Innovation, Inc.; Seattle (WA); Presencial; USD 110.000 - 160.000; Jornada completa

Descripción de la vacante

Kaleidoscope Innovation, Inc. seeks a Human Factors Engineer to advance medical devices by integrating user needs, safety, and usability across the product development lifecycle.

You will partner with engineering, marketing, medical, and regulatory teams to drive HF activities, usability studies, and regulatory submissions. You will conduct user research, lead usability studies, and perform use-related risk analyses while ensuring compliance with FDA guidance and relevant standards.

Formación

• 5–8 years of medical device experience required.
• Experience with FDA submissions and regulatory filings.
• Experience in early-stage human factors research for innovation projects.
• Planning and execution of usability studies and documentation.
• Experience with combination products or medical mobile apps is a bonus.

Responsabilidades

• Provide HF engineering guidance based on usability activity results and HF principles.
• Input user needs into product and system requirements based on HF expertise.
• Plan and conduct user research studies and usability studies with cross-functional teams.
• Lead use-related risk assessments.
• Draft technical documents for usability files within the DHF and for regulatory submissions.
• Author HF/Usability reports for regulatory submissions.
• Publish and present on HF engineering topics to internal and external audiences.
• Deliver HF educational workshops and support process improvements.

Conocimientos

Human Factors Engineering

User Research

Usability Testing

Use-related Risk Analysis

Regulatory Submissions

Cross-functional Collaboration

Descripción del empleo

Kaleidoscope Innovation, Inc. seeks a Human Factors Engineer to advance medical devices by integrating user needs, safety, and usability across the product development lifecycle.

You will partner with engineering, marketing, medical, and regulatory teams to drive HF activities, usability studies, and regulatory submissions. You will conduct user research, lead usability studies, and perform use-related risk analyses while ensuring compliance with FDA guidance and relevant standards.