Sr. Risk Management Engineer

Job description

Sr. Risk Management Engineer At Fresenius 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 our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work: We Care for our patients, each other, and our communities We Connect across teams and borders to deliver excellence together We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation At 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 a Sr. Risk Management Engineer ensures 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 Responsibilities Responsible 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 guidelines Responsible for the specification of risk reduction measures in (requirement management) cooperation of the Value Stream Ensure that all activities regarding risk management are executed according to risk management planning. Your Profile Engineering 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 regulations knowledge of medical device regulations (US Medical Devices regulation, EU MDR 2017/745, MDSAP etc.) knowledge of applicable standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR etc.) Knowledge of FMEA methodology, statistical methods, statistical methods, scientific writing. Knowledge of TrackWise, workflow, systems like QTRAK, PDM systems like PTC, Windchill, FMEA tools. Bilingual English / Spanish (excellent English communication skills required) U.S. visa required Availability to travel to the U.S. and other countries as required Our Offer for You There 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 worldwide • Individual opportunities for self‑determined career planning and professional development • A corporate culture that encourages innovative thinking—finding the best solution together, not just the fastest one • A team of committed professionals with diverse skills, talents, and experiences • The strength of a successful global corporation combined with the collegial culture of a mid‑sized company.