Senior Process Engineer
Vor 2 Tagen
Xenios AG, a leading innovator in medical device manufacturing, is seeking a skilled Senior Process Engineer to join our dynamic team at our Stolberg plant. As a key member of our production team, you will play a pivotal 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.
- 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, 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.
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