• Consulting clients on Human Factors strategy and optimization• Plan, design and manage formative and summative research studies for medical devices, including analysis of client’s needs for the piece of research, study material creation, oversight of recruitment of study participants, moderation of sessions in English, reporting of findings in appropriate format including detailed root cause analysis for all use errors• IFU and packaging creation, testing and optimization

• Stand in for client’s HF Engineer during their maternity leave• Developing and maintaining Design Control documentation for three device categories (Prefilled Syringe (PFS), pen, autoinjector) for a combination product• Oversight and preparation of Human Factors activities• Organization and oversight of formative research with external partner• Creation of Instructions for Use and training video for a phase III clinical trial involving a combination product • Support of Packaging and Labeling team in creating a new folding box + device insert for phase III clinical trials • Participation in Patient Advocacy Group (PAG) meetings with patients and patient representatives to evaluate early versions of IFU and packaging prototypes• Consolidation of anthropometric forces data to inform design engineering documentation• Work in tandem with another HF engineer, contact with other cross-functional teams as needed (Risk Management, Quality Assurance, Medicine, Design Engineering, Packaging and Labeling, etc.)

uintent is a part of ReSight Global's family of companies. Our UX and human factors research agencies in China, Germany, Japan, Switzerland, and the United States offer a broad set of tools and methods that help you to improve the user experience of your product.

• Consulting for Usability/human factors engineering and end to end project management (exploratory research, formative and summative human factors evaluations)• Project responsibilities included the design of all study materials (e.g. study protocol and session guide), submission for ethics board review, moderation of interviews in English and French, analysis and reporting of results, facilitation of client workshops• Project financial controlling

• Managing client relationships with budget oversight• Developing business opportunities• Identifying client knowledge gaps and allocation of team to execute the project

• Management of a team of five employees including Research Consultants and Associate Research Consultants• Comprehensive oversight of large scale quantitative and qualitative international research projects, focus on medical device studies and usability/human factors evaluations