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.
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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Join our Manufacturing, Quality and Supply team
Our operations division manages all manufacturing, quality assurance and supply processes within Fresenius Medical Care, the world's leading provider of products and services for people with renal diseases. It counts about 16,500 employees in 50 manufacturing and distributions centers worldwide, working across different roles to ensure our products are always best in class.
Every day, we rely on our teams in operations to make our vision become reality. Working in tight collaboration with other groups, they translate research and innovation into products and services. Creating a future worth living for our patients can only be achieved through a constant commitment to high quality and excellence, which we support with continuous training. The same commitment drives careers forward and helps our employees succeed.
Deliver high-quality products people rely on
Discover the benefits of joining a global organization that is committed to excellence and quality. We support your career journey by helping you fulfill your ambitions. That’s how we create value for our patients and our employees.
We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.