Design Quality Engineer

At Fresenius Medical Care, we are the world's leading provider in renal care and are committed to improving the lives of patients with chronic kidney diseases. Our mission is to provide high-quality and innovative products, services, and care offerings across the entire medical treatment chain. Guided by our vision - "Creating a future worth living. For patients. Worldwide. Every day." - we work with purpose and compassion, supported by a global team of over 110,000 employees. Within our Care Enablement division, we develop and deliver vital medical devices, digital health solutions, and therapies that empower clinical teams and improve treatment outcomes for patients. Our FME-Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide our actions: We care for our patients, each other, and our communities. We connect across teams and borders to achieve excellence together. We commit to doing the right things – growing with purpose and leading renal care with integrity and innovative strength.

• Advice and support on quality assurance at system level, including but not limited to system integration tests, interface tests, release readiness, and error handling
• Collaboration with interdisciplinary engineering teams from early development phases to provide input and support in quality assurance
• Evaluation of modern methods for system and electronics quality, tracking progress, and implementing improvement plans
• Definition and monitoring of quality metrics and communication of risks and quality status to stakeholders
• Creation of project-specific quality strategies and operationalization through tailored measures
• Support in managing errors, deviations, anomalies, and non-conformities
• Identification of opportunities to improve system quality processes, methods, and templates through insights and feedback
• Planning, coordination, support, review, and moderation of design FMEAs, particularly for electronic and mechatronic subsystems, to identify and address potential design weaknesses early in the development process
• Advising development teams on FMEA methodologies (e.g., dFMEA, system FMEA) as well as tool application, templates, and process optimization
• Improvement of existing product life-cycle processes and support for compliance with current regulatory requirements for medical technology systems

• Successfully completed technical degree in a scientific or engineering discipline
• At least 5 years of professional experience in product development in regulated areas, including at least 3 years in medical technology
• Experience in systems engineering and/or electronics development
• Experience in medical device development or in another regulated industry
• Sound understanding of product development processes and quality methods at system level
• Knowledge of relevant regulations and standards for medical devices, such as ISO 13485, ISO 14971, the IEC 60601 family, and related development standards, is an advantage
• Good and professional relationships and communication with colleagues and internal and external customers
• Strong communication skills due to interfaces with other departments
• Willingness to undertake occasional business trips
• Very good German and English skills, both written and spoken