Senior Medical Device Packaging Engineer

Fresenius Group; Reynosa; Presencial; MXN 420.000 - 660.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Global impact on healthcare

Career development opportunities

Culture of innovation

Diverse, collaborative team

Competitive benefits

Descripción de la vacante

Fresenius Medical Care's Reynosa plant in Mexico is seeking a Packaging Engineer 3 to lead design, development, qualification, and continuous improvement of packaging systems for medical devices. You’ll ensure packaging protects product integrity, maintains sterility where applicable, and complies with global regulatory requirements while supporting efficient manufacturing and supply chain operations.

You will design primary, secondary, and tertiary packaging, qualify materials, perform

Formación

• Bachelor’s degree in Packaging Engineering or related field.
• 3–7 years packaging engineering experience in medical devices.
• Strong knowledge of ISO 11607 and FDA QSR/21 CFR 820.
• Experience with packaging validation and distribution simulation.
• Bilingual English/Spanish; excellent communication skills.

Responsabilidades

• Design, develop and qualify packaging for sterile and non-sterile devices.
• Plan and execute packaging validations per ISO 11607.
• Support regulatory compliance with FDA/ISO standards.
• Provide manufacturing and line-support related to packaging equipment.
• Collaborate with R&D, Quality, Regulatory Affairs, Manufacturing, Supply Chain and suppliers.

Conocimientos

Packaging engineering

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Lean / Six Sigma

Educación

Bachelor's degree in Packaging Engineering

Herramientas

ISO 11607

FDA QSR / 21 CFR 820

ISO 13485

Sterilization processes (EtO, gamma, e-beam, steam)

Descripción del empleo

Fresenius Medical Care's Reynosa plant in Mexico is seeking a Packaging Engineer 3 to lead design, development, qualification, and continuous improvement of packaging systems for medical devices. You’ll ensure packaging protects product integrity, maintains sterility where applicable, and complies with global regulatory requirements while supporting efficient manufacturing and supply chain operations.

You will design primary, secondary, and tertiary packaging, qualify materials, perform