Carilion Clinic · 17 hours ago
Senior Usability Engineer - Human Factors
Roanoke, Virginia
Full-time
Onsite
Senior Level
5+ years expCarilion Clinic is a healthcare organization seeking a Senior Usability Engineer to support user-centered product research and development activities for medical devices. This role focuses on usability testing to identify and mitigate use-related risks prior to market launch, ensuring alignment with design strategies and regulatory submissions.
Child CareEducationHealth CareMedicalWellness
Responsibilities
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
Qualification
Required
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 within regulated environments (e.g., FDA, EU MDR)
Benefits
Comprehensive Medical, Dental, & Vision Benefits
Employer Funded Pension Plan, vested after five years (Voluntary 403B)
Paid Time Off (accrued from day one)
Onsite fitness studios and discounts to our Carilion Wellness centers
Access to our health and wellness app, Virgin Pulse
Discounts on childcare
Continued education and training
Company
Carilion Clinic
Carilion Clinic is a health care organization based in Virginia with more than 650 physicians in 70 specialties.
10001+ employees
H1B Sponsorship
Carilion Clinic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (19)
2023 (13)
2022 (13)
2021 (15)
2020 (31)
Funding
Current Stage
Late StageTotal Funding
$0.3MKey Investors
CDA FoundationVirginia Innovation Partnership CorporationUnitedHealthcare
2025-04-04Grant
2023-04-18Grant· $0.07M
2022-08-10Grant· $0.23M
Leadership Team
Steve Arner
President / CEO, Carilion Medical Center
Don Halliwill
Chief Financial Officer
Recent News
Research and Markets
2025-11-27
2025-05-05
Company data provided by crunchbase