Material & Metrology Engineer (m/w/d)
Epredia
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) technologiesConsult internal customers regarding selection of the most suitable measurement method to address the topic in question in a best possible mannerMeasure polymer-based medical devices and related components via computed tomographyCharacterize surfaces of polymeric medical device components via scanning electron microscopyConduct microanalytical investigations of suspicious structures via EDX detection in the context of complaint handlingsDevelop and apply etching and contrasting methods facilitating material characterizationDevelop and apply immunocytochemical staining techniques to characterize blood-material interactions by light and electron microscopyDefine and adequately prepare test samples for required measuring methodsSupport product development and sustaining projects as well as complaint management activities and root cause analyses by delivering and analyzing high-quality measurement dataPresent measurement results and analyses in international x-functional project teamsMaintain a fit-for-purpose HRI equipment as well as an always audit ready equipment related documentationContinuously enhance understanding regarding state-of-the-art measurement equipment and processesElaborate foresighted proposals for required equipment extensions and introduction of meaningful additional analytical capabilitiesDefine technical and user requirements for new equipment, request and analyze quotations, and contribute to pricing negotiations with suppliersPrepare and present reasonable business cases to derive respective investment approvalsSelf-reliant development and documentation of measurement methodsEnsure adequacy of measurement equipment and processes through analyses of measurement systems conducting Gage R&R and determining process capabilityAutonomously 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 processesValidate new and adjusted measurement processesAdvise Product Engineers regarding preparation of component related drawings ensuring compliance with applicable ISO standardsLead x-site harmonization of high-resolution measurement equipment and methodsQualification profile
Broad knowledge of diverse measurement and surface analysis related methods such as computed tomography, SEM, AFM, IRM, XPS, SIMS, AES and Raman spectroscopyBachelor’s degree in related discipline and/or 5+ years relevant experience in a metrology laboratoryExpert knowledge of metrology standards (e.g. ISO 1101, ISO 5459, ISO 8015, ISO 14405, ISO 17450)Skilled in coordinate metrologyExperienced in development and application of automated measurement processesCapable 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 validationsEquipped with CAD construction and reverse engineering skillsUnderstanding of polymeric base materials as well as respective processing and joining technologiesExperienced in GDP compliant documentation and archiving of measurement development and training, raw data and reports, and equipment qualificationFamiliarity 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 EnglishPersonal qualities
Self-reliant and proactive working behaviourTeam-minded person able to efficiently collaborate in matrix structuresHigh quality awarenessAbility to independently prioritize tasksExperience working in high-performance international and x-functional project teamsTakes accountability for and delivers consistent results in line with quality and timeline expectationsAbility to build effective relationships with all relevant internal and external stakeholdersGood presentation skillsSelf-confident personality able to represent results as well as the team’s interests regarding material and metrology related questions towards internal and external stakeholdersOur offer to you:
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert and how much experience you bring with you - for your professional future with meaning:
The opportunity to work on a mobile basisWhether in front of or behind the scenes - you will help to make better and better therapy available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution togetherA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized company
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