Senior Usability Engineer - Human Factors

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.

Education: Bachelor's 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.

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For more information, contact the HR Service Center at 1-800-599-2537.

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 800-599-2537, 8:00 a.m. to 4:30 p.m., Monday through Friday.

For more information on E-Verify: https://www.carilionclinic.org/eoe-e-verify-and-right-work-policies

Carilion understands the importance of prioritizing your well-being to help you develop and thrive. That's why we offer a well-rounded benefits package, and many perks and well-being resources to help you live a happy, healthy life - at work and when you're away.

When you make your tomorrow with us, we'll enhance your potential to realize the best in yourself.Below are benefits available to you when you join Carilion:

• 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

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