Senior Usability Engineer - Human Factors

Carilion Clinic•Roanoke, VA

1d•Onsite

About The Position

The Senior Usability Engineer works within a structured usability engineering process to support user-centered product research and development activities for medical devices. This role focuses on the planning, execution, and documentation of usability testing to identify and mitigate use-related risks prior to market launch. The Senior Usability Engineer Supports medical device (software and hardware) design and development in accordance with international standards and regulatory expectations (e.g., FDA, IEC 62366, ANSI/AAMI HE75). Develops and implements robust qualitative and quantitative research protocols to evaluate early-stage concepts, developmental prototypes, and final designs across the full product development lifecycle – including formative evaluations and summative usability validation studies. Identifies and characterizes user needs and constraints through direct user engagements, translating findings into actionable usability recommendations and interface design guidance. Assumes primary ownership of specific client products while also supporting other projects and programs as needed across the consulting portfolio. Ensures continued alignment of human factors and usability engineering efforts with overall design strategies and regulatory submissions across the System. Develops an understanding of specific client business needs and product management considerations to better inform design decisions and align usability efforts with market objectives. Assist with preparation of new business documents and materials such as client proposals, project resourcing and budget estimates, marketing materials, statements of work, etc. to facilitate client engagements and future business growth.

Requirements

Bachelor's degree in Human Factors, Biomedical Engineering, Industrial Engineering, Cognitive Psychology, or related field.
Minimum 5 years of experience in Human Factors Engineering, including 3 years specifically in the medical device or combination product domain.
User research methods (contextual inquiry, interviews, surveys), task analysis and use-related risk analysis, formative and summative usability testing, root cause analysis of usability issues, core HFE deliverables (Use Specifications, Usability Evaluation Reports), regulatory requirements and standards (FDA Guidance, IEC 62366, ANSI/AAMI HE75, IEC 14971, etc.), strong analytical thinking and problem-solving ability, excellent written and verbal communication skills, ability to work independently and collaboratively in cross-functional teams, adaptability in a fast-paced, client-driven consulting setting, demonstrated experience applying FDA Human Factors guidance, IEC 62366, and ISO 14971 standards, experience working withing regulated environments (e.g., FDA, EU MDR).

Responsibilities

Planning, execution, and documentation of usability testing to identify and mitigate use-related risks prior to market launch.
Supports medical device (software and hardware) design and development in accordance with international standards and regulatory expectations (e.g., FDA, IEC 62366, ANSI/AAMI HE75).
Develops and implements robust qualitative and quantitative research protocols to evaluate early-stage concepts, developmental prototypes, and final designs across the full product development lifecycle – including formative evaluations and summative usability validation studies.
Identifies and characterizes user needs and constraints through direct user engagements, translating findings into actionable usability recommendations and interface design guidance.
Assumes primary ownership of specific client products while also supporting other projects and programs as needed across the consulting portfolio.
Ensures continued alignment of human factors and usability engineering efforts with overall design strategies and regulatory submissions across the System.
Develops an understanding of specific client business needs and product management considerations to better inform design decisions and align usability efforts with market objectives.
Assist with preparation of new business documents and materials such as client proposals, project resourcing and budget estimates, marketing materials, statements of work, etc. to facilitate client engagements and future business growth.