Human Factors Engineer & Service Lead.

ppbYour main tasks /b /p /p liTake end-to-end responsibility for establishing Human Factors (HF) as a service offering and drive the acquisition of HF service projects in close collaboration with Business Development /li liAct as a trusted advisor to pharmaceutical customers on HF strategies for combination products, with a strong focus on efficient regulatory pathways and ensuring that service offerings are aligned with customer needs /li liConduct and coordinate international HF studies, including setting timelines and budgets and planning, monitoring, and documenting formative, summative, and comparative use HF studies, including studies involving large participant cohorts /li liManage external consultants, vendors, and testing facilities as required /li liLead or support HF activities related to Instructions for Use (IFU) and user interfaces as part of the overall HF program /li liCreate, maintain, and review usability engineering documentation required for regulatory submissions, such as study reports, HF reports, and threshold analyses, in close collaboration with customer teams and internal stakeholders /li liCollaborate closely within the Science Evidence team to translate insights from HF studies and user populations into strategic publications, evidence-generation activities, and market differentiation /li liStay current with the global HF regulatory landscape and contribute to shaping Ypsomed’s position in collaboration with industry bodies and consortium representatives /li ppbYour profile /b /p /p liA Bachelor’s or Master’s degree in Human Factors, Ergonomics, Usability Engineering, Product Design, Psychology, or a related field, combined with at least 7 years of professional experience as a Human Factors consultant, including experience within the combination product or related medical device industry /li liAn entrepreneurial mindset, a strong sense of ownership, strong business acumen, and a clear understanding of how to develop, position, and scale value-adding service offerings in a customer-focused environment /li liExtensive hands-on experience in planning, conducting, and documenting large-scale Human Factors studies for medical devices and/or combination products, as well as strong project management skills and proven experience managing multiple complex projects simultaneously /li liExperience with international development programs and regulatory submissions across key markets, including the United States (FDA), the European Union (EU MDR), China (NMPA), and Canada (Health Canada) /li liExceptional interpersonal and communication skills, with English proficiency at C1 level or above; German is an asset. Demonstrated ability to work effectively across cultures in diverse, international environments /li liWillingness to travel internationally approximately % of the time, including to the United States; authorization to travel to the United States is therefore required /li Hinweis: Für diese Position berücksichtigen wir keine Bewerbungen von Personalvermittlern. Job openings for professionals - Ypsomed ppbYour benefits /b /p /p ppbPension fund /b /p /p Ypsomed covers % of the pension contributions ppbMobility support /b /p /p Charging stations, Swiss Half Fare Card, parking, close to public transport ppbFree sport facilities /b /p /p Affordable or free gyms all over Switzerland ppbFamily friendly /b /p /p Financial contributions to childcare ppbWorking hours /b /p /p Shiftwork, annual working hours, part-time ppbFlexWork /b /p /p Work where and when you want (in Switzerland) ppbUp-to-date work environment /b /p /p Up-to-date production, offices, break areas Your Ypsomed work environment ppbYpsomed - making the treatment of chronic diseases possible /b /p /p More than 2, employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.