Human Factors Engineer

Kaleidoscope Innovation; 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

Human Factors Engineer

We are seeking a Human Factors Engineer to support the development of innovative medical devices and combination products by ensuring user needs, safety, and usability are integrated throughout the product development lifecycle. This individual will partner closely with cross-functional teams including engineering, marketing, medical, and regulatory affairs to plan, execute, and document human factors activities that support product design decisions and regulatory submissions. The role will focus on conducting user research, leading usability studies, performing use-related risk assessments, and ensuring compliance with FDA guidance and applicable human factors standards.

Key Responsibilities Include

• Provide expert Human Factors Engineering guidance based on usability activity results and Human Factors Engineering principles
• Provide use-related input into the creation of product and system requirements based on user needs and Human Factors Engineering expertise
• Partner with marketing, medical, engineering and others to plan and conduct Human Factors Engineering activities, including but not limited to:
• Conceptualizing, organize, and lead the conduct of user research studies (e.g., contextual inquires, dairy studies, observational studies)
• Lead the development of protocols, study designs, and execution of formative and summative (HF Validation) usability studies
• Conduct heuristic evaluations and expert reviews
• Conduct use-related risk analysis
• Lead the reporting and disposition of Human Factors Engineering evaluation findings
• Draft technical documents (e.g., use-specification) for usability files within the DHF and as guidance for late-stage development
• Author Human Factors Engineering / Usability Engineering reports for regulatory submission
• Serve as an opinion leader, internally and externally, including seeking opportunities to publish and speak publicly about Human Factors Engineering
• Conducts Human Factors Engineering educational workshops and seminars to multi-functional audiences
• Assist in internal Human Factors Engineering staff training and process improvement activitiesAssist in maintaining procedures and tools on best practices related to Human Factors Engineering

It is also important that individuals in this role ensure the following:

• User capabilities and limitations and associated use-related risks are appropriately addressed in planning, requirements development, and design & engineering
• User performance characteristics and their associated benefits and risks assist in deciding among design alternatives
• Compliance to relevant standards (IEC 62366, ANSI/AAMI HE75, etc.) and FDA guidance is adequately addressed in Human Factors Engineering processes and deliverables

Education/Experience

• 5-8 years of experience with medical devices and FDA submissions
• Experience in early-stage human factors research/activities in innovation/early phase projects
• Planning and executing usability studies, and preparing FDA submission documents
• Combination product or medical mobile app experience is a bonus but not necessary