Human Factors Engineer & Service Lead

Position

Festanstellung

Lead

Ingenieurwesen

Konditionen

Burgdorf, Switzerland

80–100%

Anforderungen

7+ J. Erfahrung

Bachelor

EU/EFTA-Bewilligung

Sprachen

Englisch C1

Deutsch

Beschreibung

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.

Aufgaben

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

Anforderungen

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

Vorteile

Interesting job content
Promising development opportunities
Attractive employment conditions
Prospect of helping to shape the innovation-driven and quality-oriented world of medical technology

Unternehmen

Ypsomed

Medical Technology

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.

Kontakt

Heiko Sieger

+41344242634