Associate-Director, Human Factors and Usability Engineering

Role Summary

Associate-Director, Human Factors and Usability Engineering. Leads and executes HFUE activities, drives user-centric design, and optimizes product user-interface to ensure safety, effectiveness, and optimal user experience across the product pipeline. Oversees HFUE initiatives from early stage through development and life cycle management, delivering timely, rigorous results.

Responsibilities

• Lead human factors and usability engineering activities throughout the product lifecycle
• Ensure product safety, effectiveness, and optimal user-interface design
• Drive user-centered design processes supporting the product pipeline
• Collaborate with cross-functional teams to implement HFE best practices
• Oversee regulatory compliance and documentation

Qualifications

• Required: Bachelor‚Äôs or master‚Äôs degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences or Psychology, Industrial Design or related field
• Required: Extensive experience in pharmaceutical or medical device industry
• Required: Deep knowledge of combination products and medical device human factors
• Required: Strong understanding of FDA Guidance, International Standards, and Global Regulations
• Preferred: Wide range of FDA submission experience
• Preferred: Multidisciplinary perspective in device design, user research, instructional design, requirements generation, and user-centric design across the product lifecycle

Skills

• Strategic implementation of HFUE processes: user needs identification, use requirements generation, context of use definition, use-related risk controls assessment, URRA execution, study design and execution, UEF/DHF deliverable management, regulatory submission documentation
• Leadership competencies: strategic thinking, risk-based decision making, agile leadership, critical problem-solving, innovation-driven approach, excellent communication and collaboration

Education

• Formal degree in a related field as listed above