Senior Usability Engineer Human Factors
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Job Location:
Roanoke, VA - USA
Monthly Salary:
Not Disclosed
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
Employment Status:
Full timeShift:
Day (United States of America)Facility:
15 Old Woods Ave SE - RoanokeRequisition Number:
R157948 Senior Usability Engineer - Human Factors (Open)How Youll Help Transform Healthcare:
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.
What We Require:
Education: Bachelors degree in Human Factors Biomedical Engineering Industrial Engineering Cognitive Psychology or related field.
Experience: Minimum 5 years of experience in Human Factors Engineering including 3 years specifically in the medical device or combination product domain.
Other Minimum Qualifications: 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).
This job description is only meant to be a representative summary of the major responsibilities and accountabilities performed by the incumbents of this job. The incumbents may be requested to perform job-related tasks other than those stated in this description.
Recruiter:
RHONDA JOHNSONRecruiter Email:
For more information contact the HR Service Center at 1-.
Carilion Clinic is an Equal Opportunity Employer: We provide equal employment opportunities to all employees and applicants without regard to race color religion sex national origin age (40 or older) disability genetic information or veterans status. Carilion is a Drug-Free Workplace. For more information or for individuals with disabilities needing special assistance with our online application process contact Carilion HR Service Center at 8:00 a.m. to 4:30 p.m. Monday through Friday.
Required Experience:
Senior IC
Key Skills
- Project / Program Management
- CSS
- FDA Regulations
- Data Collection
- Ux
- Usability
- GAMP
- Assistive Technologies
- Application Development
- Product Lifecycle Management
- Process Engineering
- UI
