Senior Human Factors and Usability Engineer

About This Role

This role involves executing and supporting Human Factors and Usability Engineering activities for Sanofi's parenteral injection systems, ensuring products are safe, effective, and user-friendly. You will contribute to regulatory submissions, user needs analysis, UI design, and validation studies, while also expanding HF/UE knowledge and participating in international standards organizations.

Responsibilities

• Execute and support GDPU HF/UE activities from early engagement through LCM
• Contribute to submission strategies and planning
• Conduct user needs analysis and support user requirements development
• Perform task analysis and conduct use-related risk analysis
• Support user interface (UI) design
• Execute formative and summative validation studies
• Contribute to expanding HF/UE knowledge and participate in international standards organizations
• Build and apply knowledge and network in industry, patient associations, and with regulators
• Serve as a key contributor to regulatory and association interactions outside Sanofi
• Support usability engineering and Human Factors compliance with authority expectations and contribute to regulatory interactions

Requirements

• Extensive experience in the pharmaceutical or medical device industry
• Strong knowledge and practical application of human factors engineering, design controls, and risk management standards and guidances (e.g., IEC 62366, FDA HF Guidance, ISO 14971) across end-to-end combination product development
• Demonstrated analytical thinking, problem-solving, and research design skills; ability to analyze data with proficiency in basic statistics
• Experience planning and executing ethnographic, formative, and summative usability studies, with or without external vendors
• Ability to translate study insights and technical constraints into clear user needs and actionable design recommendations
• Strong cross-functional collaboration and interpersonal skills
• Ability to work independently with appropriate guidance and oversight

Qualifications

• Bachelor’s or master’s degree in Human Factors Engineering, Biomedical Engineering, Biomechanics, Mechanical Engineering, HF Behavioral Sciences, Psychology, Industrial Design, or related field.

Nice to Have

• Experience in package design and development of safety-critical information to support product use and user interface design
• Experience creating instructional materials and patient support programs for new product introductions and on-market support
• Working knowledge of periodic risk reviews and change control processes for on-market drug-device combination products
• Experience with health authority submissions and interactions (e.g., FDA, EMA, Notified Bodies)
• Understanding of drug-device development and the integration of HF/UE with market research, risk management, design controls, and lifecycle management processes
• Expertise in human factors engineering, usability engineering, and user-centered design principles for medical devices and combination products
• Ability to adapt to a rapidly changing environment

Skills

* Required skills

Benefits