Entry Level - Sustaining Engineer

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

Who We AreABOUT ENOVISEnovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.What You'll DoSummary:Collaborates in the development of robust manufacturing processes, visual aids, work methods/instructions, and rework plans, and resolves issues using engineering techniques (line balancing, 8D problem-solving, among others).Supports the execution of validation protocols (IQ, OQ, PQ).Provides support during initial production runs.Assists in tracking NCMRs/CAPAs and ensures assigned actions are completed accurately and on time.Participates in the design of assembly equipment, ergonomic workstations, fixtures, and tooling for assembly and subassembly operations.Contributes to achieving established objectives.Participates in continuous improvement projects in collaboration with OPEX (Operational Excellence).Participates in the evaluation and implementation of product and process changes, root cause analysis, scrap reduction, process capability improvement, and product transfer or insourcing activities, as applicable.Maintains GMP documentation in compliance with ISO 13485, FDA requirements, and other regulations applicable to manufacturing processes.Adheres to Standard Operating Procedures (SOPs) and operational standards for manufacturing engineering functions.Plans, manages, and monitors projects using project management methodologies and tools, such as Work Breakdown Structure (WBS).Qualifications:Bachelor's degree in Industrial, Mechanical, Electronic Engineering, or a related field.Minimum of 1 year of experience in a Manufacturing Engineering role within a 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 (Measurement System Analysis) and SPC (Statistical Process Control).Knowledge of Lean Manufacturing tools and methodologies, including Kaizen, Gemba, SMED, PDCA, DMAIC, Bottleneck Analysis, Root Cause Analysis, 5S, Poka-Yoke, and Just-in-Time (JIT).Knowledge of Project Management methodologies and tools, including Work Breakdown Structure (WBS) and Critical Path Method (CPM).Kindly upload your English resume.EQUAL EMPLOYMENT OPPORTUNITYEnovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.