Senior Manufacturing Engineer
vor 3 Wochen
Fresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day. Xenios, a subsidiary of Fresenius Medical Care, is a leading innovator in the manufacture of medical devices for lung and heart treatment. Our Xenios plant in Stolberg manufactures life-sustaining products for the treatment of patients who need lung and heart support. These include patient kits and our Xenios consoles.
Xenios is seeking a skilled Senior Manufacturing Engineer to join our dynamic team at our Stolberg plant. You will play a pivotal role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives within our medical device production. Join Xenios and be part of a dedicated team committed to improving patient care through cutting-edge medical technology.
Tasks
Lead the development, optimization, and validation of manufacturing processes for medical devices and patient kits. Collaborate with cross-functional teams to ensure the seamless transfer of products from R&D to full-scale production, focusing on efficiency, quality, and scalability. Conduct feasibility studies, process validations, and equipment qualifications to ensure compliance with regulatory standards (ISO, FDA, etc.). Collaborate with suppliers and external partners to evaluate new technologies, materials, and equipment for process enhancements. Leading interdisciplinary project teams in technical matters Representing Head of Process Industrialization & Change Management in technical matters. Supervision and qualification of new processes/production facilities (FAT - Factory Acceptance Test / SAT - Site Acceptance Test, IQ - Installation Qualification, OQ - Operational Qualification, process validation, machine capability analyses). Transition of assemblies and products from development to serial production. Supervision of pilot series. Active implementation of "Design to Cost," "Design to Quality," and "Design for Manufacturing" for existing products and new product developments. Prototype construction, initial sampling, and documentation creation. Development of technical specifications for new manufacturing equipment and process risk analyses (FMEAs). Project management in development and rationalization projects.Profile
Your personality is characterized by a high level of drive, positive mindset and energy. You are a reliable, detail-oriented, and a safety-conscious individual. The successful candidate is a team player, has a strong attention to detail, and is committed to quality & safety.
Degree in Mechanical Engineering, Industrial Engineering or other related field. Professional experience as an engineer in the healthcare sector Experience as a project manager for development and rationalization projects. Experience in the manufacturing and development of medical devices is advantageous. Desirable experience in Industrial Engineering and optimizing production processes. Knowledge in project management and modern project planning methods. Experience with regulatory compliance standards and guidelines (ISO 13485, FDA QSR) related to medical device manufacturing. Proficiency in process simulation software, CAD tools, statistical analysis, and manufacturing ERP systems. Excellent problem-solving skills, analytical mindset, and the ability to work effectively in cross-functional teams. Strong communication skills in German and English, both written and verbal. Willingness to travel as part of project-related activities. Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.-
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