Senior Manufacturing Engineer – Medical Devices & Lean Excellence

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; Presencial; MXN 680.000 - 900.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care Reynosa plant is seeking a Sr. Manufacturing Engineer to develop and optimize manufacturing processes for high-quality dialysis components. You will lead process validation, drive cost efficiency, and collaborate across cross-functional teams in a regulated environment.

The role requires strong lean, PFMEA, and CAD skills, plus bilingual English/Spanish communication. Join a global leader delivering life-saving products with continuous improvement mindset.

Formación

• Bachelor’s degree in Industrial, Mechanical, Mechatronics, Electronics, or related Engineering field.
• Experience in manufacturing engineering, preferably in medical devices.
• Strong knowledge of process validation, PFMEA, and manufacturing documentation.
• Experience with Lean tools, line balance, and time & motion studies.
• SolidWorks or CAD experience.
• Strong analytical and problem-solving skills.
• Ability to communicate effectively across all organizational levels.
• Proactive and results-oriented mindset.
• Advanced computer skills (Microsoft Office, Project).
• Bilingual (English/Spanish).
• U.S. Visa required.

Responsabilidades

• Develop and improve manufacturing processes for new and existing products.
• Design layouts, production lines, fixtures, and poka-yokes to optimize operations.
• Lead process validation activities, including protocol development, execution, and reporting.
• Support troubleshooting and root cause analysis for manufacturing issues.
• Drive continuous improvement initiatives focused on cost reduction, quality, and efficiency.
• Collaborate with suppliers and internal teams to ensure process consistency and compliance.
• Develop and maintain manufacturing documentation (work instructions, procedures, validation reports).
• Support change control processes and implementation of validated improvements.
• Lead rework process development and associated documentation (protocols, PFMEA, visual aids).
• Participate in CAPAs, non-conformities, and quality improvement activities.
• Apply Lean tools and data analysis to optimize operational performance.
• Support strategic plant initiatives and KPI tracking.

Conocimientos

Lean tools

PFMEA

SolidWorks or CAD

Analytical skills

Bilingual English/Spanish

Office/Project tools

Educación

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

Herramientas

SolidWorks

CAD software

Descripción del empleo

Fresenius Medical Care Reynosa plant is seeking a Sr. Manufacturing Engineer to develop and optimize manufacturing processes for high-quality dialysis components. You will lead process validation, drive cost efficiency, and collaborate across cross-functional teams in a regulated environment.

The role requires strong lean, PFMEA, and CAD skills, plus bilingual English/Spanish communication. Join a global leader delivering life-saving products with continuous improvement mindset.