Medical Device Component Engineer - NPI & Quality

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

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