Sustaining Engineer — Manufacturing Excellence

DJ Orthopedics De Mexico, S.A. DE C.V.; México; On-site; MXN 360,000 - 480,000; Full time

Job summary

Enovis Corporation seeks a Manufacturing Engineer to help develop robust manufacturing processes, create visual aids, and implement efficient work methods for assembly and subassembly operations. You will support IQ/OQ/PQ validations and monitor initial production runs in a highly regulated environment.

The role requires a Bachelor's degree in engineering, at least 1 year of maquiladora experience, and solid knowledge of lean tools, ISO 13485, and core engineering tools.

Qualifications

• Bachelor's degree in Industrial, Mechanical, Electronic Engineering or related field.
• 1+ year in Manufacturing Engineering in maquiladora/manufacturing environment.
• Intermediate English proficiency (technical reading and conversational skills).
• Knowledge of IQ/OQ/PQ Validation Protocols and ISO 13485 requirements.
• Familiarity with Engineering Core Tools, such as MSA and SPC.
• Knowledge of Lean Manufacturing tools and methodologies (Kaizen, 5S, SMED, PDCA, DMAIC, JIT).
• Knowledge of Project Management methodologies and tools (WBS and CPM).

Responsibilities

• Collaborates in development of robust manufacturing processes, visual aids, work methods/instructions, and rework plans.
• Supports execution of IQ/OQ/PQ validation protocols and initial production runs.
• Assists in tracking NCMRs/CAPAs and ensures actions are completed on time.
• Participates in design of assembly equipment, ergonomic workstations, fixtures, and tooling.
• Contributes to continuous improvement projects with OPEX.
• Evaluates product/process changes, root cause analysis, scrap reduction, and product transfer/insourcing as applicable.
• Maintains GMP documentation per ISO 13485, FDA, and other regulations.
• Adheres to SOPs and uses project management methodologies like WBS.

Skills

Industrial/Mechanical/Electrical Eng.

Intermediate English

Lean manufacturing concepts

Quality/regulatory understanding

Education

Bachelor's degree in Industrial/Mechanical/Electronic Eng.

Tools

MSA

SPC

WBS

CPM

Job description

Enovis Corporation seeks a Manufacturing Engineer to help develop robust manufacturing processes, create visual aids, and implement efficient work methods for assembly and subassembly operations. You will support IQ/OQ/PQ validations and monitor initial production runs in a highly regulated environment.

The role requires a Bachelor's degree in engineering, at least 1 year of maquiladora experience, and solid knowledge of lean tools, ISO 13485, and core engineering tools.