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Be successful together: We look forward to making a decisive contribution to our success story with you in our Risk Team at our headquarters in Burgdorf.

Ref. No. 7098

Location: Burgdorf | Hybrid

Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.

• Ensure that our products comply with the latest standards in risk management, specifically observing ISO 14971, ISO 13485, and Part 820 during product development and lifecycle
  Represent risk management in audits conducted by Notified Bodies, Competent Authorities, and pharma-customers
  Collaborate with various teams, including development, usability engineering, and production, acting as a service provider and partner to ensure effective communication and information flow among project stakeholders
  Assist project and product management teams, such as testing, to ensure the successful implementation of risk control measures
  Contribute to the continuous improvement of risk management processes within the organization
  Utilize software tools for risk analysis, including FMEA and FA work

• Bachelor’s degree or higher in Engineering or Science
  Minimum of 2 years of working experience in Design and Development (D&D), ideally in product risk management of medical or IVD devices (preferably active medical devices or combination products) or other GMP-regulated areas
  Expertise in software risk management and service security is advantageous
  Familiarity with software tools for risk analysis (FMEA, FA) is beneficial
  Proficiency in German (B2 level) and English (for documentation purposes)
  Strong communication capabilities are essential
  A team-oriented personality and a strong team player mindset

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.

Gregor Stoffel
HR Recruiting Partner

+41 (0) 34 424 28 65

Burgdorf