Manufacturing Sustaining Engineer: Process Improvement

Enovis; Tijuana; On-site; MXN 739,000 - 1,108,000; Full time

Job summary

Enovis in Mexico is seeking a Manufacturing Engineer to help develop robust production processes, validation activities (IQ/OQ/PQ), and sustain GMP/document controls in ISO 13485 environments. You will support initial production runs and collaborate with OPEX on continuous improvement.

The role emphasizes line balancing, tooling design, and process capability improvements; requires 1+ year in maquiladora settings, intermediate English, and knowledge of MSA/SPC, Lean tools, and project management

Qualifications

• Bachelor's degree in Industrial, Mechanical, Electronic Engineering.
• Minimum of 1 year of experience in Manufacturing Engineering in maquiladora environment.
• Intermediate English proficiency (technical reading and conversational).
• Knowledge of IQ/OQ/PQ Validation Protocols and ISO 13485.
• Familiarity with MSA and SPC.
• Lean tools: Kaizen, Gemba, SMED, PDCA, DMAIC, 5S, Poka-Yoke, JIT.
• Project management with WBS and CPM.

Responsibilities

• Collaborates in development of robust manufacturing processes and work methods.
• Supports validation protocols (IQ, OQ, PQ) and initial production runs.
• Tracks NCMRs/CAPAs and ensures actions are completed on time.
• Participates in design of assembly equipment, fixtures, and tooling.
• Contributes to continuous improvement with OPEX and product transfers.
• Maintains GMP documentation per ISO 13485 and FDA requirements; adheres to SOPs.

Skills

Lean manufacturing

Gemba

Kaizen

5S

Poka-Yoke

DMAIC

Root cause analysis

Just-in-Time

PDCA

WBS

CPM

Education

Bachelor's degree in Industrial, Mechanical, Electronic Engineering

Tools

MSA

SPC

IQ/OQ/PQ

ISO 13485

WBS

CPM

Job description

Enovis in Mexico is seeking a Manufacturing Engineer to help develop robust production processes, validation activities (IQ/OQ/PQ), and sustain GMP/document controls in ISO 13485 environments. You will support initial production runs and collaborate with OPEX on continuous improvement.

The role emphasizes line balancing, tooling design, and process capability improvements; requires 1+ year in maquiladora settings, intermediate English, and knowledge of MSA/SPC, Lean tools, and project management