Component Engineer

Fresenius Medical Care; Reynosa; Presencial; MXN 180.000 - 280.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care is seeking a Component Engineer to support selection, qualification, and lifecycle management of electrical and mechanical components used in our medical devices at the Reynosa plant. You will collaborate with Engineering, Manufacturing, Quality, Purchasing, and Suppliers to ensure compliance with quality, regulatory, and reliability requirements.

The role emphasizes BOM review, supplier audits, and timely activities to sustain product availability, reduce risk, and enable

Formación

• Bachelor’s degree in Industrial, Electronics, Mechanical, Mechatronics, or related Engineering field.
• 1+ year of experience in Engineering, Manufacturing, Change Control, Product Support, or a related field.
• Experience in Design, Sustaining, or Manufacturing Engineering within Active Medical Devices (AMD) is preferred.
• Knowledge of SAP, Bills of Materials (BOMs), product costing, and investment analysis.
• Understanding of Printed Circuit Board Assembly (PCBA), cables and harnesses, and metal/plastic fabrication processes.
• Understanding of New Product Introduction (NPI) and manufacturing environments.
• Experience with SAP, Windchill, and IHS software is a plus.
• Strong analytical, problem-solving, and project management skills.
• Excellent verbal and written communication skills.
• Ability to work independently and in cross-functional teams.

Responsabilidades

• Support the identification, evaluation, and qualification of electrical and mechanical components for new and existing products
• Develop and execute component evaluation, acceptance, qualification, verification, validation, and reliability test plans
• Identify and qualify alternate sources and second-source components to improve material availability, reliability, and cost effectiveness
• Collaborate with Design Engineering, Manufacturing, Sustaining Engineering, Quality, Purchasing, and Suppliers to support component-related projects and production needs
• Investigate component failures, coordinate failure analysis activities, and drive corrective actions with component manufacturers
• Review, analyze, and optimize Bills of Materials (BOMs) at the manufacturer part level
• Support Risk Management activities and maintain related documentation
• Draft, 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 requirements
• Ensure purchased components and subassemblies comply with applicable standards and regulations including RoHS, REACH, UL, CE, CSA, ISO, IPC‑A‑610, and Conflict Minerals requirements
• Maintain 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 manufacturers
• Lead End‑of‑Life (EOL) management activities by monitoring component lifecycles and implementing solutions to minimize business impacts
• Participate in supplier audits and support supplier quality initiatives as required
• Serve as the primary technical contact for Contract Manufacturing partners regarding component‑related issues
• Monitor component technology trends and support New Product Introduction (NPI) and manufacturing activities

Conocimientos

Bilingual English/Spanish

Analytical skills

Project management

Educación

Bachelor’s degree in Industrial, Electronics, Mechanical, Mechatronics, or related Engineering field

Herramientas

SAP

Windchill

IHS software

Descripción del empleo

Component 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.

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 Responsibilities

• Support the identification, evaluation, and qualification of electrical and mechanical components for new and existing products
• Develop and execute component evaluation, acceptance, qualification, verification, validation, and reliability test plans
• Identify and qualify alternate sources and second‑source components to improve material availability, reliability, and cost effectiveness
• Collaborate with Design Engineering, Manufacturing, Sustaining Engineering, Quality, Purchasing, and Suppliers to support component‑related projects and production needs
• Investigate component failures, coordinate failure analysis activities, and drive corrective actions with component manufacturers
• Review, analyze, and optimize Bills of Materials (BOMs) at the manufacturer part level
• Support Risk Management activities and maintain related documentation
• Draft, 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 requirements
• Ensure purchased components and subassemblies comply with applicable standards and regulations including RoHS, REACH, UL, CE, CSA, ISO, IPC‑A‑610, and Conflict Minerals requirements
• Maintain 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 manufacturers
• Lead End‑of‑Life (EOL) management activities by monitoring component lifecycles and implementing solutions to minimize business impacts
• Participate in supplier audits and support supplier quality initiatives as required
• Serve as the primary technical contact for Contract Manufacturing partners regarding component‑related issues
• Monitor component technology trends and support New Product Introduction (NPI) and manufacturing activities

Your Profile

• Bachelor’s degree in Industrial, Electronics, Mechanical, Mechatronics, or related Engineering field
• 1+ 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 apply
• Experience in Design, Sustaining, or Manufacturing Engineering within Active Medical Devices (AMD) is preferred
• Knowledge of hemodialysis and peritoneal dialysis equipment is preferred
• Knowledge of SAP, Bills of Materials (BOMs), product costing, and investment analysis
• Understanding of Printed Circuit Board Assembly (PCBA), cables and harnesses, and metal/plastic fabrication processes
• Understanding of New Product Introduction (NPI) and manufacturing environments
• Experience with SAP, Windchill, and IHS software is a plus
• Strong analytical, problem‑solving, and project management skills
• Excellent verbal and written communication skills
• Ability to work independently and in cross‑functional teams
• Advanced computer skills including Microsoft Excel, Word, and MS Project
• Strong organizational, data analysis, and presentation skills
• Ability to manage multiple priorities in a fast‑paced environment
• Bilingual (English/Spanish)
• U.S. Visa required
• Availability to travel to the U.S. and other countries as required

Our Offer for You

• 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.