Senior Manufacturing Engineer, Med Device Automation

TekniPlex; Ciudad Juárez; Presencial; MXN 700.000 - 1.050.000; Jornada completa

Descripción de la vacante

TekniPlex Healthcare is seeking a Senior Manufacturing Engineer in Ciudad Juárez, Mexico, to lead strategic manufacturing initiatives in a regulated medical device environment. The role emphasizes process development, validation, automation, and cross-functional project leadership.

Ideal candidates bring 5+ years in manufacturing engineering, experience with process validation, and knowledge of FDA/ISO13485/GMP guidelines, enabling improvements in productivity, quality, and compliance.

Formación

• Bachelor's degree in Engineering or related field.
• 5+ years of Manufacturing Engineering experience.
• Medical device manufacturing experience preferred.
• Experience with process validation and regulatory requirements.

Responsabilidades

• Lead manufacturing process development and continuous improvement initiatives.
• Implement Lean Manufacturing and Six Sigma projects to improve productivity and quality.
• Lead process and equipment validation activities (IQ/OQ/PQ).
• Support New Product Introduction (NPI) and process transfer activities.
• Develop and maintain SOPs, PFMEAs, control plans, and work instructions.
• Analyze manufacturing metrics and drive performance improvements.

Conocimientos

Lean Six Sigma

Process Validation

Regulatory Understanding

Project Leadership

English Proficiency

Analytical Thinking

Educación

Bachelor's degree in Engineering

Advanced English

Herramientas

Minitab

ERP systems

Descripción del empleo

TekniPlex Healthcare is seeking a Senior Manufacturing Engineer in Ciudad Juárez, Mexico, to lead strategic manufacturing initiatives in a regulated medical device environment. The role emphasizes process development, validation, automation, and cross-functional project leadership.

Ideal candidates bring 5+ years in manufacturing engineering, experience with process validation, and knowledge of FDA/ISO13485/GMP guidelines, enabling improvements in productivity, quality, and compliance.