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