Your main tasks
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
Your 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.
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