Usability Engineer

Job Summary:
As a Usability Engineer at Cyient, you will play a vital role in driving human-centered design for innovative medical devices and healthcare solutions. You will lead the development of user scenarios, conduct usability risk assessments (UFMEAs), evaluate user feedback from complaints, and execute both formative and summative usability studies. Working in a cross-functional Agile environment, you will ensure usability goals align with product milestones and regulatory standards, including FDA guidance and IEC 62366.

Key Responsibilities:

• Develop and refine use scenarios, user flows, and task analyses based on product requirements and clinical workflows.
• Conduct Use Failure Modes and Effects Analyses (UFMEAs) to identify and mitigate usability risks throughout the development lifecycle.
• Lead or support the review of customer complaints to identify usability-related issues and drive continuous product improvement.
• Design and execute formative and summative usability studies, including protocol development, participant recruitment, data collection and analysis, and reporting.
• Ensure compliance with relevant regulatory standards, including FDA Human Factors Guidance, IEC 62366, and ISO 14971.
• Collaborate with cross-functional teams (Design, R&D, Quality, Regulatory, Clinical) to deliver user-centric solutions aligned with design controls and risk management processes.
• Contribute to the creation and maintenance of Design History Files (DHFs) and support regulatory submissions with usability documentation.
• Participate actively in Agile ceremonies (e.g., sprint planning, reviews, retrospectives), using Scrum, Kanban, or similar frameworks to deliver usability milestones within sprint timelines.
• Ensure transparency, prioritization, and alignment of usability engineering tasks across the overall product development lifecycle.