Material & Metrology Engineer in Sankt Wendel bei Fresenius Medical Care

Fresenius Medical Care is the world's leading provider of products and services, offering innovative products and treatment concepts of the highest quality. We are committed to continuously improving the quality of life of our dialysis patients, worldwide and every day.
Join our team and play a crucial role in shaping the future of dialysis treatment by driving impactful innovations and strategies that improve patient outcomes on a global scale!

Job specification

• Provide high-quality measurement data to Value Stream Bloodlines & Concentrates and Value Steam Dialyzers applying appropriate High-Resolution Imaging (HRI) technologies
• Consult internal customers regarding selection of the most suitable measurement method to address the topic in question in a best possible manner
• Measure polymer-based medical devices and related components via computed tomography
• Characterize surfaces of polymeric medical device components via scanning electron microscopy
• Conduct microanalytical investigations of suspicious structures via EDX detection in the context of complaint handlings
• Develop and apply etching and contrasting methods facilitating material characterization
• Develop and apply immunocytochemical staining techniques to characterize blood-material interactions by light and electron microscopy
• Define and adequately prepare test samples for required measuring methods
• Support product development and sustaining projects as well as complaint management activities and root cause analyses by delivering and analyzing high-quality measurement data
• Present measurement results and analyses in international x-functional project teams
• Maintain a fit-for-purpose HRI equipment as well as an always audit ready equipment related documentation
• Continuously enhance understanding regarding state-of-the-art measurement equipment and processes
• Elaborate foresighted proposals for required equipment extensions and introduction of meaningful additional analytical capabilities
• Define technical and user requirements for new equipment, request and analyze quotations, and contribute to pricing negotiations with suppliers
• Prepare and present reasonable business cases to derive respective investment approvals
• Self-reliant development and documentation of measurement methods
• Ensure adequacy of measurement equipment and processes through analyses of measurement systems conducting Gage R&R and determining process capability
• Autonomously advance measurement methods incl. creation of holders and fixtures for an optimized sample intake aiming at best possible quality of results and efficiency of measurement processes
• Validate new and adjusted measurement processes
• Advise Product Engineers regarding preparation of component related drawings ensuring compliance with applicable ISO standards
• Lead x-site harmonization of high-resolution measurement equipment and methods

Qualification profile

• Broad knowledge of diverse measurement and surface analysis related methods such as computed tomography, SEM, AFM, IRM, XPS, SIMS, AES and Raman spectroscopy
• Bachelor’s degree in related discipline and/or 5+ years relevant experience in a metrology laboratory
• Expert knowledge of metrology standards (e.g. ISO 1101, ISO 5459, ISO 8015, ISO 14405, ISO 17450)
• Skilled in coordinate metrology
• Experienced in development and application of automated measurement processes
• Capable to conduct shape and position tolerance calculations in line with applicable standards (ISO 1101, ASME Y 14.5, ISO 14405)
• Ability to perform measurement system analyses and process validations
• Equipped with CAD construction and reverse engineering skills
• Understanding of polymeric base materials as well as respective processing and joining technologies
• Experienced in GDP compliant documentation and archiving of measurement development and training, raw data and reports, and equipment qualification
• Familiarity with applicable regulatory standards concerning development of medical devices in general (MDR, ISO 13485) and bloodlines for extracorporeal circuits in particular (ISO 8637-2) as well as requirements for testing laboratories (ISO 17025) is considered beneficial
• Fluent command in spoken and written English

Personal qualities

• Self-reliant and proactive working behaviour
• Team-minded person able to efficiently collaborate in matrix structures
• High quality awareness
• Ability to independently prioritize tasks
• Experience working in high-performance international and x-functional project teams
• Takes accountability for and delivers consistent results in line with quality a