Usability Engineer || Cleveland Ohio

Hello

Role - Usability Engineer

Location Cleveland Ohio

Experience 4 7 Years

Domain - Healthcare / Medical Technology domain

Responsibilities:

• Conducts usability activities across all development phases in collaboration with multidisciplinary teams including UI/UX, product design, clinical, R&D, and system engineering.
• Define the usability engineering approach for projects, including planning activities, resources, and usability integration throughout development.
• Conduct and lead user research, usability testing (formative and summative), task analysis, and risk assessments (usability FMEA), and generate documentation for regulatory submissions (FDA, EU-MDR, CMDE).
• Identify, analyze, and document usability risks and potential use errors through comprehensive usability risk analyses.
• Plan, conduct, and report usability studies in compliance with privacy, usability, and legal requirements, including NDAs, site agreements, and informed consent.
• Analyze post market data and create Human Factors Engineering and usability documentation to demonstrate product safety, effectiveness, and regulatory compliance.
• Collaborate with cross-functional teams including engineering, clinical, marketing, quality, regulatory, and service to deliver human-centered solutions that meet global medical device standards.
• Work on usability documentation and report outs related to usability studies like expert review, formative evaluation and summative usability evaluations.
• Create usability testing protocols, select user profiles, create usability test plans and prioritize feedback and findings into safety, critical and other categories.
• Stay ahead of usability regulations (IEC 62366, ISO 14971, FDA guidance) and advise teams on compliant, user-focused product development.

Skills:

• Bachelor's or Master's degree in Industrial Design, Product Design, Cognitive Psychology, or a related field with a focus on Human Factors or Human-Computer Interaction (HCI).
• 5+ years of experience in usability, human factors, or user-centered design ideally in medical devices or other high-regulation industries (aviation, automotive, military).
• Strong research and communication skills, with the ability to translate user needs into actionable design input and strategic direction.
• Familiar with medical device usability and risk management standards (e.g., IEC 62366, FDA guidance, ISO 14971, EU-MDR).