Human Factors Services Manager

Ypsomed · Burgdorf

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.

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