About the Role
The primary focus of this position is to ensure compliance with the latest risk management standards, specifically ISO and Part, throughout product development and lifecycle.
This includes representing risk management in audits conducted by Notified Bodies, Competent Authorities, and pharma-customers, as well as collaborating with various teams to facilitate effective communication and information flow among project stakeholders.
In addition, you will assist project and product management teams in implementing risk control measures and contribute to the continuous improvement of risk management processes within the organization.
Utilizing software tools for risk analysis, including FMEA and FA work, is also a key aspect of this role.
Your Profile
We are seeking an individual with a Bachelor's degree or higher in Engineering or Science, who has a minimum of 2 years of working experience in Design and Development (D&D), preferably in product risk management of medical or IVD devices.
Expertise in software risk management and service security is advantageous, as is familiarity with software tools for risk analysis.
Proficiency in German (B2 level) and English (for documentation purposes) is required, along with strong communication capabilities and a team-oriented personality.
Benefits
We offer a range of benefits, including pension fund contributions, mobility support, free sport facilities, family-friendly financial contributions, flexible working hours, and a modern work environment.
As part of the Ypsomed Group, we have over employees worldwide developing and producing injection and infusion systems for self-medication.
Our market-leading products and solutions enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, and certain types of cancer.