* Ensure that our products comply with the latest standards in risk management, specifically observing ISO, ISO, and Part 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
Benefits
* Pension fund: Ypsomed covers % 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
* Working hours: Shiftwork, annual working hours, part-time
* FlexWork: Work where and when you want (in Switzerland)
* Up-to-date work environment: Up-to-date production, offices, break areas
Ypsomed - making the treatment of chronic diseases possible
More than 2, 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.
#J-18808-Ljbffr