Senior Process Engineer (m/f/d)

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 Process 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

• Set up, operate, maintain and shutting down fully automated production machinery according to FMC company procedures.
• Lead process engineering activities for the manufacturing of medical devices and patient kits, from design to full-scale production.
• Design, develop, and improve manufacturing processes to enhance efficiency, quality, and cost-effectiveness.
• Collaborate with cross-functional teams including R&D, Operations, and Quality Assurance to ensure seamless product transfers and process validations.
• Drive continuous improvement initiatives, implementing Lean Manufacturing principles and methodologies.
• Analyze production data, identify areas for optimization, and implement solutions to enhance process performance and yield.
• Develop and maintain process documentation, including SOPs, work instructions, and validation protocols.
• Lead troubleshooting efforts for process-related issues and implement corrective actions.
• Participate in equipment selection, qualification, and technology transfer activities.
• Technical leadership of project teams.
• Approval of concepts, specifications, and documents within the scope of projects
• Supervision of series production of assemblies for medical technology (focus on Disposables).
• Maintenance of technical master data in the ERP system.
• Handling corrective and preventive actions (CAPA/Non-conformity) for quality issues including fault analysis, rectification, and documentation.
• Support in the qualification and validation of newly introduced and existing production processes.

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 Production Engineering, Mechanical Engineering with a specialization in Manufacturing Technology, Medical Engineering, Plastic Engineering, Precision Engineering, or equivalent education.
• Strong knowledge of manufacturing principles, process optimization, lean manufacturing methodologies, and quality management systems.
• 5+ years of 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, 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.