Title:  Human Factors Services Manager

Your main tasks

• Take end-to-end responsibility for establishing, reporting and scaling Human Factors (HF) services as an offering for pharma customers. Drive the acquisition of HF service projects in close collaboration with Business Development 
• Act as a trusted advisor to pharma customers on Human Factors and usability engineering strategies for combination products and drug-delivery systems, with a strong focus on efficient regulatory pathways, ensuring that service offerings are aligned with customer needs
• Coordinate several international HF studies in parallel, including timelines, budgets, test facilities and study deliverables. Plan, lead, monitor and document formative, summative and comparative use Human Factors studies, including studies with large participant cohorts and across multiple markets. Select, manage and steer external consultants and vendors where needed
• Take responsibility for or support Instructions for Use (IFU) and user interface-related HF input as part of the overall Human Factors Engineering program
• Create, maintain and review usability engineering documentation (e.g. study reports, HFE report and threshold analysis) required for regulatory submissions in close collaboration with customer teams and internal stakeholders
• Closely collaborate within Science & Evidence team to feed insights from HF studies and user populations into strategic publications, evidence generation and market differentiation
• Develop and implement a Human Factors data pooling strategy to leverage existing knowledge, increase efficiency and reduce study size, timelines, costs and resource demands where appropriate 
• Stay current with the global Human Factors regulatory landscape and contribute to shaping Ypsomed’s position in collaboration with industry bodies and consortium representatives

Your profile

• Bachelor’s, Master’s or PhD degree in Human Factors, Ergonomics, Usability Engineering, Product Design, Psychology or a related field with at least 7 years of professional experience as Human Factors consultant in leading roles in the combination product or related medical device industry
• Entrepreneurial mindset and strong ownership. Strong business acumen and a clear understanding of how to develop, position and scale value-adding service offerings in a customer-focused environment
• Strong hands-on experience in planning, conducting and documenting large Human Factors studies for medical devices and/or combination products. Strong project management skills and experience managing multiple complex projects simultaneously
• Experience with international regulatory submissions and development programs (EU MDR, USA FDA, China NMPA, Health Canada, etc.)
• Exceptional interpersonal and communication skills in English (C1); German is an asset. Demonstrated ability to work cross-culturally in diverse and international environments
• Willingness to travel internationally up to approximately 20–30%, including travel to the United States; accordingly, authorization for traveling to the United States is required