Component Engineer At Fresenius Medical CareWe 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 integral 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.The Component Engineer supports the selection, qualification, and lifecycle management of electrical and mechanical components used in our medical devices.
This role works closely with Engineering, Manufacturing, Quality, Purchasing, and Suppliers to ensure components meet quality, performance, reliability, and regulatory requirements while supporting business continuity and product innovation.Your ResponsibilitiesSupport the identification, evaluation, and qualification of electrical and mechanical components for new and existing productsDevelop and execute component evaluation, acceptance, qualification, verification, validation,



and reliability test plansIdentify and qualify alternate sources and second-source components to improve material availability, reliability, and cost effectivenessCollaborate with Design Engineering, Manufacturing, Sustaining Engineering, Quality, Purchasing, and Suppliers to support component-related projects and production needsInvestigate component failures, coordinate failure analysis activities, and drive corrective actions with component manufacturersReview, analyze, and optimize Bills of Materials (BOMs) at the manufacturer part levelSupport Risk Management activities and maintain related documentationDraft, review, and implement validation protocols, validation reports, GMP procedures, performance qualifications, and Engineering Change Orders (ECOs)Maintain validation records and support ongoing compliance with Quality System requirementsEnsure purchased components and subassemblies comply with applicable standards and regulations including RoHS, REACH, UL, CE, CSA, ISO, IPC-A-610, and Conflict Minerals requirementsMaintain and execute updates to the Approved Manufacturer List (AML) and support Engineering Change Orders (ECOs) and Manufacturing Change Orders (MCOs)Review, assess, and track Product Change Notifications (PCNs) from component manufacturersLead End-of-Life (EOL) management activities by monitoring component lifecycles and implementing solutions to minimize business impactsParticipate in supplier audits and support supplier quality initiatives as requiredServe as the primary technical contact for Contract Manufacturing partners regarding component-related issuesMonitor component technology trends and support New Product Introduction (NPI) and manufacturing activitiesYour ProfileBachelor's degree in Industrial, Electronics, Mechanical, Mechatronics, or related Engineering field1+ year of experience in Engineering, Manufacturing, Change Control, Product Support, or a related field; recent graduates with relevant internship or project experience are encouraged to applyExperience in Design, Sustaining, or Manufacturing Engineering within Active Medical Devices (AMD)



is preferredKnowledge of hemodialysis and peritoneal dialysis equipment is preferredKnowledge of SAP, Bills of Materials (BOMs), product costing, and investment analysisUnderstanding of Printed Circuit Board Assembly (PCBA), cables and harnesses, and metal/plastic fabrication processesUnderstanding of New Product Introduction (NPI) and manufacturing environmentsExperience with SAP, Windchill, and IHS software is a plusStrong analytical, problem-solving, and project management skillsExcellent verbal and written communication skillsAbility to work independently and in cross-functional teamsAdvanced computer skills including Microsoft Excel, Word, and MS ProjectStrong organizational, data analysis, and presentation skillsAbility to manage multiple priorities in a fast-paced environmentBilingual (English/Spanish)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.
Creating a future worth living.
For patients.
Worldwide.
Every day.Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment.
United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe.
In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables.
We aim to continuously improve our patients' quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.
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📌 Component Engineer (Reynosa)
🏢 Ch01 Che Fresenius Medical Care (Schweiz
📍 Reynosa