Ypsomed seeks a Senior Human Factors Services Manager in Burgdorf, CH, to lead HF service projects, advise pharmaceutical clients, and manage regulatory usability engineering for combination products.
The company is looking for a senior professional to establish Human Factors as a distinct service offering and secure new business opportunities. In this capacity, the individual will serve as a trusted advisor to pharmaceutical customers, guiding them on HF strategies for combination products while ensuring alignment with global regulatory standards.
Responsibilities
- Plan and coordinate international Human Factors studies, managing associated timelines and budgets.
- Oversee external consultants, vendors, and testing facilities to ensure project success.
- Lead or support Human Factors activities concerning Instructions for Use (IFU) and user interfaces.
- Develop, maintain, and review usability engineering documentation required for regulatory submissions.
- Convert insights from Human Factors studies into strategic publications and evidence-generation activities.
- Monitor the global Human Factors regulatory landscape and help shape the company’s position on emerging trends.
Requirements
- Bachelor’s or Master’s degree in Human Factors, Ergonomics, Usability Engineering, Product Design, Psychology, or a related discipline.
- Minimum of seven years of professional experience as a Human Factors consultant.
- Prior experience within the combination product or related medical device industry.
- Extensive hands-on experience in planning, conducting, and documenting large-scale Human Factors studies for medical devices or combination products.
- Strong project management skills with a proven track record of managing multiple complex projects simultaneously.
- Experience with international development programs and regulatory submissions across key markets (FDA, EU MDR, NMPA, Health Canada).
- English proficiency at C1 level or above.
- Authorization to travel to the United States.
Nice to have
- German language proficiency.
What the company offers
- Pension fund: Ypsomed covers 55% of the pension contributions.
- Mobility support: Charging stations, Swiss Half Fare Card, parking, close to public transport.
- Free sport facilities: Affordable or free gyms all over Switzerland.
- Family friendly: Financial contributions to childcare.
- FlexWork: Work where and when you want (in Switzerland).
- Up-to-date work environment: Up-to-date production, offices, break areas.
About the company
Ypsomed values an entrepreneurial mindset, strong sense of ownership, and strong business acumen.
- Entrepreneurial mindset.
- Strong sense of ownership.
- Strong business acumen.
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.