Usability Engineer 2, Design Assurance

Principal Responsibilities

• Develop protocols and execute usability engineering activities across new product development and sustaining projects in alignment with FDA human factors guidance, IEC 62366, ISO 14971, internal design control procedures, and applicable quality system requirements.
• Conduct and document use specifications, task analyses, user needs assessments, identification of critical tasks, and use-related risk analyses to inform product design and risk management activities.
• Plan, execute, and document formative and summative usability evaluations, including protocol development, participant definition, data collection, study moderation, analysis, and report generation.
• Analyze usability study data to identify usability issues, residual risks, and opportunities for design improvement; recommend appropriate risk controls involving design, labeling, and training as applicable.
• Collaborate with R&D, Quality, Regulatory Affairs, Clinical/Medical Affairs, Marketing, Manufacturing, and Business Unit stakeholders to align usability objectives with project priorities, design requirements, and timelines.
• Collaborate in the recruitment of qualified clinicians for usability studies and moderate usability testing sessions in collaboration with engineering resources.
• Support investigation of usability-related issues, including root cause analysis and corrective/preventive actions (CAPA) or nonconformance activities, as assigned.
• Ensure compliance with company policies, the Code of Ethics, and procedural standards, maintaining high-quality output throughout all usability engineering activities.

Education / Experience Requirements

• BS in Engineering, Usability Engineering / Ergonomics, Usability Engineering, Cognitive Psychology, Behavioral Psychology, Industrial Design or equivalent degree or related field with relevant work experience demonstrating acquisition and application of position-relevant skills.
• 2 to 4 years of usability engineering or design assurance, preferably within the medical device or other regulated industry.

Specialized Skills / Other Requirements

• Strong working knowledge of FDA Human Factors guidance (Applying Human Factors and Usability Engineering to Medical Devices), IEC 62366 (Application of usability engineering to medical devices), and ISO 14971 (Medical devices — Application of risk management to medical devices).
• Solid understanding of design controls, product development processes, and the role of Design Assurance throughout the product lifecycle.
• Proficiency in planning, moderating, analyzing, and documenting formative and summative usability evaluations and related human factors deliverables.