Medical Device Manufacturing Engineer — Process & Validation

Fresenius Medical Care; Reynosa; Presencial; MXN 350.000 - 520.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care in Reynosa, Mexico is seeking a Manufacturing Engineer to develop, validate, and improve manufacturing processes for dialysis components in a highly regulated medical device environment.

You will collaborate with Manufacturing, Quality, Operations, and Engineering teams to support new product introductions, process validations, and continuous improvement initiatives, applying Lean principles and risk management.

Formación

• Bachelor's degree in a related engineering field is required.
• Experience with GMP, FDA requirements, CAPA, NC, Risk Management, and Quality Systems.
• Proficiency in SolidWorks and CAD software.

Responsabilidades

• Develop and optimize manufacturing processes for new and existing products.
• Support Product Risk Management and continuous improvement of manufacturing and Quality System processes.
• Create and maintain validation protocols, reports, GMP procedures, and ECOs per FDA requirements.
• Design manufacturing fixtures, gauges, and assembly tools using SolidWorks.
• Lead production line adjustments and support engineering studies and revalidation activities.
• Investigate validation failures and CQAs, supporting CAPAs and NC investigations.
• Evaluate process changes via DCAF, VCA, and VP assessments and implement improvements.
• Lead rework activities with protocol development, work instructions, and pFMEA documentation.
• Apply Lean tools, time and motion studies, line balancing, Pareto analysis, and process mapping.
• Support plant strategic projects, KPI tracking, customer complaint investigations, and CI initiatives.

Conocimientos

Analytical thinking

Problem solving

Communication

Lean Manufacturing

Educación

Bachelor's Degree in Industrial, Mechanical, Electronics, Mechatronics, Manufacturing Engineering, or related field

Herramientas

SolidWorks

Descripción del empleo

Fresenius Medical Care in Reynosa, Mexico is seeking a Manufacturing Engineer to develop, validate, and improve manufacturing processes for dialysis components in a highly regulated medical device environment.

You will collaborate with Manufacturing, Quality, Operations, and Engineering teams to support new product introductions, process validations, and continuous improvement initiatives, applying Lean principles and risk management.