At Ypsomed, we are shaping the future of medical technology together - with the aim of sustainably improving the quality of life for people with chronic conditions. We promote an open corporate culture in which diversity is valued, and new perspectives are welcome. Our employees take responsibility, work in an interdisciplinary manner and develop innovative solutions with real added value for society.
As our Human Factors Engineer & Service Lead, you will build and grow Ypsomed's Human Factors service offering for pharmaceutical partners worldwide. You will advise customers on Human Factors strategies, lead international HF programs, and contribute to innovative combination products. With your expertise, you will help deliver user-centered solutions that support successful regulatory approvals.
Human Factors Engineer & Service Lead | 80 - 100%
Ref. No. 7961
Location: Burgdorf | Hybrid
Your main tasks
- Take 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
- Act 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
- Conduct 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
- Manage external consultants, vendors, and testing facilities as required
- Lead or support HF activities related to Instructions for Use (IFU) and user interfaces as part of the overall HF program
- Create, 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
- Collaborate closely within the Science & Evidence team to translate insights from HF studies and user populations into strategic publications, evidence-generation activities, and market differentiation
- Stay current with the global HF regulatory landscape and contribute to shaping Ypsomed’s position in collaboration with industry bodies and consortium representatives
Your profile
- A 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
- An 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
- Extensive 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
- Experience 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)
- Exceptional 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
- Willingness to travel internationally approximately 20% of the time, including to the United States; authorization to travel to the United States is therefore required
Ypsomed - making the treatment of chronic diseases possible
More than 2,000 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.
Contact
Heiko Sieger
Workforce Acquisition & Engagement Partner
Your future place of work
Burgdorf