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.

Risk Manager | 80 - 100%

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.

Your main tasks

[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]

Your profile

[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]

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

Gregor Stoffel
HR Recruiting Partner

+41 (0) 34 424 28 65

Your future place of work

Burgdorf

Burgdorf