Fresenius Medical Care Deutschland GmbH | Germany | 97xxx Schweinfurt | Permanent position | Full time | Published since: 21.04.2026 on stepstone.de
Software Risk Manager (m/f/d)
Fresenius Medical Care is a global leader in kidney care and has committed itself to improving the quality of life of patients with chronic kidney disease. Our mission is to offer high-quality, innovative products, services and care throughout the entire health process. Based on our vision – “To create a life-saving future. For patients. Worldwide. Every day.” – we work targeted and compassionate, supported by a global team of over 125,000 employees. In our Care Enablement segment, we develop and deliver life-saving medical products, digital health solutions and therapies that support clinical teams and improve patient treatment outcomes. Our FME Reignite strategy is driving change through innovation, efficiency and sustainable growth. Our values guide our work: We take care of our patients and our communities We connect teams and borders to deliver top performance together We commit ourselves to doing things right – to grow with a goal and to lead kidney care with integrity and innovation Our location in Schweinfurt plays an important role in our global production of medical devices for dialysis. With their expertise and commitment, more than 1400 employees contribute to ensuring that our products meet the highest quality standards – about a third of them work in research and development. Since 2019, Schweinfurt also has a technology centre with an area of around 8000 square meters. Around 220 specialists from different disciplines work together to advance the development of our dialysis machines. We manufacture medical devices specifically designed for hemodialysis (HD), peritoneal dialysis (PD) and acute care. Become part of this team and make an important contribution to the further development and improvement of dialysis therapy worldwide. This role is about ensuring the systematic management of software-related risks as part of the new or further development of dialysis devices to ensure product safety and regulatory compliance. .
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Your tasks • Your profile • What we offer
Planning, implementation and continuous maintenance of software risk management according to relevant standards (e.g. ISO 14971, IEC 62304) Identification, assessment and documentation of software-related risks and risks over the entire product life cycle Creation and maintenance of risk analysis and the associated risk management file for software Definition and follow-up of risk control measures in close cooperation with software development, system architecture and quality assurance Monitoring the effectiveness of implemented measures and updating risk status for changes Coordination and moderation of software-hazard analyses as well as support of higher-level device-hazard analysis Ensuring consistency between software, system and safety risks Planning, coordination and maintenance of software FMEAs (e.g. design and process FMEA) including coordination with the higher-level product risk management Close interface work with product risk managers to ensure consistent risk analysis across system, hardware and software levels Integration of software FMEA results into overall risk assessment and device-hazard analysis Support for internal and external audits and regulatory audits in the field of software risk management Training and consulting of development teams in relation to risk identification and assessment
Complete study of computer science, medical technology, engineering or a comparable qualification At least 5 years of professional experience in software development and/or risk management Ideally experience in the medical technology or healthcare technology industry Experience in product development under formal design controls and quality management systems Knowledge of relevant standards (e.g. IEC 62304, IEC 61508, ISO 26262 or DO-178C) Experience in global, cross-functional and intercultural teams Safe handling of common software development tools and MS Office Very good knowledge of German and English in word and writing Standing for occasional national and international missions (approximately 10%) High reliability, care and independent operation Impressed organisational capacity Analytical thinking and structured approach Communication strength and team capacity
At Fresenius Medical Care there is a lot to discover, regardless of which area you are an expert (m/w/d) and how much experience you bring with you – all in the service of your career. Whether in front of or behind the scenes – you contribute to getting more and more people around the world access to ever better medicine. Individual opportunities for self-determined career planning and professional development A corporate culture where there is enough space for innovative thinking – to find the best solution together, not the fastest A large number of committed people with diverse skills, talents and experiences The advantages of a successful global group with the collegial culture of a medium-sized company
Location
 | Fresenius Medical Care Deutschland GmbH | |
| 97424 Schweinfurt | ||
| Germany |
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