Senior Usability Engineer

https://jobs.sanofi.com/en/job/cambridge/senior-usability-engineer/2649/12394374976

Responsibilities

• Develops Human Factors / Usability Engineering (HF/UE) strategies and executes all activities for development projects for Sanofi products across the portfolio including medical device, drug-device combination products, drug-delivery device technology, and medicinal products as appropriate to ensure User Interface (UI) Design of the product supports safe and effective use and minimizes potential use error. HF/UE activities are performed with appropriate rigor and in a timely manner.
• Collaborates closely with clinical, regulatory, device, quality/ risk management, and other functions to harmonize expectations and ways of working together that satisfy Design History File/Design Control requirements including risk management, verification and validation, and HF specific requirements such as development of user needs, user requirements, context of use, UI-Design evaluation, hazard analysis, user-related risk analysis, and HF validation. 
• Develops and executes fit-for-purpose HF Plans including defining user needs and user requirements, performing task analysis, informing user interface (UI) design, defining research/ evaluation methods, analyzing data, performing use-related risk analysis, supporting all aspects of formative and summative validation studies, developing submission content, and to contributing continuous improvement efforts.
• Ability to translate user insights into user needs/ requirements, provide inputs to support iterative UI-design processes, define appropriate HF research methods based upon phase, complexity and scale of project, analyze study/research results, translate findings back into design and integrate into use-related risk analysis.
• Capable of designing, planning, executing variety of HF research methods with or without the support of external consultants

Qualifications

• Industry experience in HF/UE in medical devices, drug delivery systems, drug-device combination products, SaMD, IVD, and/or medicinal products.
• Strong foundation in HF/UE principles and relevant human factors, design controls, and risk management regulations, standards, and guidance's for medical devices and (drug-device) combination products.
• Critical thinking, Decision-making, complex problem solving, and root cause analysis.
• Time management, able to lead/support multiple programs across various development phases.
• Effective written and verbal communication across matrix organization.