Human Factors Engineer

INFOSYS NOVA HOLDINGS•Seattle, WA

About The Position

We are seeking a Human Factors Engineer to support development of innovative medical devices and combination products by integrating user needs, safety, and usability throughout the product development lifecycle. The role partners with cross-functional teams, including engineering, marketing, medical, and regulatory affairs, to plan, execute, and document human factors activities that inform product design decisions and regulatory submissions. It focuses on user research, usability studies, use-related risk assessments, and compliance with FDA guidance and applicable human factors standards. The Human Factors Engineer ensures that user capabilities and limitations, use-related risks, and user performance characteristics are considered in planning, requirements development, and design and engineering. The role also helps teams use the benefits and risks of user performance to decide among design alternatives and ensures relevant standards and FDA guidance are addressed in human factors processes and deliverables.

Requirements

5–8 years of experience with medical devices and FDA submissions.
Experience with early-stage human factors research and activities in innovation or early-phase projects.
Experience planning and executing usability studies and preparing FDA submission documents.

Nice To Haves

Combination product experience.
Medical mobile app experience.

Responsibilities

Provide Human Factors Engineering guidance based on usability activity results and Human Factors Engineering principles.
Provide use-related input into product and system requirements based on user needs and Human Factors Engineering expertise.
Partner with marketing, medical, engineering, and other teams to plan and conduct Human Factors Engineering activities.
Conceptualize, organize, and lead user research studies, such as contextual inquiries, diary studies, and observational studies.
Lead the development of protocols and study designs, and execute formative and summative usability studies, including Human Factors validation.
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, such as use specifications, for usability files within the DHF and to guide late-stage development.
Author Human Factors Engineering and Usability Engineering reports for regulatory submissions.
Serve as an internal and external opinion leader, including seeking opportunities to publish and speak publicly about Human Factors Engineering.
Conduct Human Factors Engineering educational workshops and seminars for multifunctional audiences.
Assist with internal Human Factors Engineering staff training and process improvement activities.
Assist in maintaining procedures and tools related to Human Factors Engineering best practices.
Ensure user capabilities, limitations, use-related risks, and user performance characteristics are addressed in planning, requirements development, and design and engineering.
Ensure relevant standards, including IEC 62366 and ANSI/AAMI HE75, and FDA guidance are addressed in Human Factors Engineering processes and deliverables.