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  • Senior Process Engineer

    vor 2 Monaten


    Stolberg (Rhineland), Deutschland XENIOS AG Vollzeit

    Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. As a global health care company, we have a special goal: provide the best possible care. Join us to improve the quality of life for a growing number of patients around the world and be a vital part of our team....+ ← ...

Senior Process Engineer

vor 2 Monaten


Stolberg Rhld, Deutschland Fresenius Medical Care Vollzeit
About Fresenius Medical Care

Fresenius Medical Care is a leading global provider of products and services for patients with chronic kidney disease. Our mission is to improve the quality of life for our patients worldwide.

Job Summary

We are seeking a highly skilled Senior Process Engineer to join our team at our Stolberg plant. As a Senior Process Engineer, you will play a key role in optimizing manufacturing processes, ensuring product quality, and driving continuous improvement initiatives within our medical device production.

Key Responsibilities
  • Set up, operate, maintain, and shut down fully automated production machinery according to 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, focusing 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.
Requirements
  • 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.