Sr.risk management engineeratfresenius medical care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease.our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.guided by our vision -"creating a future worth living. For patients. Worldwide. Every day."- we work with purpose and compassion, supported by a global team of over 110,000 employees.within ourcare enablementsegment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes.ourfme reignitestrategy drives transformation through innovation, efficiency, and sustainable growth.our values guide how we work:we carefor our patients, each other, and our communitieswe connectacross teams and borders to deliver excellence togetherwe committo doing things the right way - growing with purpose and leading kidney care with integrity and innovationat our reynosa plant in mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments.with a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (pd) disposables, hemodialysis (hd) machines, and pd cycler machines.by utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we're not only driving innovation-we're also creating meaningful change for patients worldwide.join our passionate team and be part of this global impact.as asr.risk management engineerensures product safety for medical devices, by applying the risk management process throughout the product life cycle.will ensure risks are identified and addressed in accordance with the risk management plan, planning and execution of risk management process, the preparation and maintenance of the risk analysis for assigned medical devices and medicinal products (and if applicable for non-medical active or digital devices) in compliance with relevant standards and guidelines.your responsibilitiesresponsible for planning and execution of system risk management processes, the preparation and maintenance of the risk analysis for assigned medical and medicinal devices (and if applicable for non-medical active or digital devices) in compliance with relevant standards and guidelinesresponsible for the specification of risk reduction measures in (requirement management) cooperation of the value streamensure that all activities regarding risk management are executed according to risk management planning.your profileengineering degree or equivalent experience.minimum 2 - 4 years of experience in similar areas of quality engineering for manufacturing processes, (medical devices preferably).
experience of 1-3 years in research and development, regulatory affairs or risk management (medical devices preferably).
experience with risk management expertise.bilingual english / spanish (excellent english communication skills required)knowledge of medical device risk management and related regulationsknowledge of medical device regulations (us medical devices regulation, eu mdr *, mdsap etc.)knowledge of applicable standards (e. g. Iso*, iso*, ich q10, eu gmp, fda 21 cfr etc.)knowledge of fmea methodology, statistical methods, scientific writing.knowledge of trackwise, workflow, systems like qtrak, pdm systems like ptc, windchill, fmea tools.u.s. visa requiredavailability to travel to the u.s. and other countries as requiredour offer for youthere is a lot you can discover at fresenius medical care, regardless of the field of expertise or level of experience - everything is dedicated to supporting your professional journey.whether in front of or behind the scenes, you help make better medicine available to more people worldwideindividual opportunities for self‐determined career planning and professional developmenta corporate culture that encourages innovative thinking - finding the best solution together, not just the fastest onea team of committed professionals with diverse skills, talents, and experiencesthe strength of a successful global corporation combined with the collegial culture of a mid‐sized company.
#j-*-ljbffr