Manufacturing Engineer | Lean Six Sigma for Medical Devices

TekniPlex; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

TekniPlex Healthcare in Ciudad Juárez, Mexico, is seeking a Manufacturing Engineer to design, optimize, and improve production processes for greater efficiency, quality, and safety.

You will drive continuous improvement using Lean and Six Sigma, validate processes, and maintain compliance with FDA/ISO13485 requirements.

This role requires 3 years of experience in production and cost reduction, with a degree in Industrial or related engineering.

Formación

• Industrial, Biomedical, Process, Electromechanical, or Mechatronics engineering degree.
• Minimum 3 years of experience in production processes and continuous improvement.
• Experience in cost reduction and resource optimization.

Responsabilidades

• Ensure production line uptime and continuity by solving technical problems.
• Drive continuous improvement with Lean and Six Sigma, root-cause analysis, optimization, line balancing, and Kaizen.
• Manage design, documentation, and updating of work/process instructions, line balancing, and validation.
• Apply validation tools (IQ/OQ/PQ) and maintain FDA and ISO 13485 knowledge.
• Maintain effective customer communication and provide status updates on process changes.
• Use PFMEA, 8D, SPC, Poka-Yoke, SMED, control charts, VSM, Gantt, and CAD for plant systems and maintenance.
• Manage projects including NPI, lead continuous improvement initiatives, and perform cost analyses.
• Safety: uphold safe processes and equipment in collaboration with Maintenance and EHS.
• Quality: deliver processes that meet high quality standards.

Conocimientos

Lean Six Sigma

Root cause analysis

Line balancing

Process optimization

New technologies

Kaizen

CAD software

SPC

Educación

Industrial Engineering

Biomedical Engineering

Process Engineering

Electromechanical Engineering

Mechatronics

Herramientas

CAD software

PFMEA

Quality systems

Gantt charts

Descripción del empleo

TekniPlex Healthcare in Ciudad Juárez, Mexico, is seeking a Manufacturing Engineer to design, optimize, and improve production processes for greater efficiency, quality, and safety.

You will drive continuous improvement using Lean and Six Sigma, validate processes, and maintain compliance with FDA/ISO13485 requirements.

This role requires 3 years of experience in production and cost reduction, with a degree in Industrial or related engineering.