Manufacturing Process Engineer - Lean Six Sigma & GMP

Medtronic; Matamoros; On-site; MXN 600,000 - 900,000; Full time

Job summary

Medtronic in Matamoros, Mexico, seeks a Manufacturing Engineer to lead development and optimization of production processes for medical technologies, working with Operations, Quality, R&D and Supply Chain to ensure scalable, compliant manufacturing.

You will drive equipment qualification and validation (IQ/OQ/PQ), support technology transfer and new product introductions, and apply Lean/Six Sigma, DOE, SPC, and MSA to improve quality, throughput, and cost performance while complying with FDA

Qualifications

• Bachelor's degree in Engineering with 4+ years in manufacturing engineering or Master's with 2+ years, or PhD.
• Experience applying Lean Manufacturing and Six Sigma in regulated environments.
• Experience with DOE, SPC, MSA, and process capability analysis.

Responsibilities

• Lead the development, optimization, and sustainment of manufacturing processes to improve quality, efficiency, throughput, and yield.
• Drive continuous improvement using Lean Manufacturing, Six Sigma, and statistical methodologies to reduce waste and improve process capability.
• Identify, evaluate, and implement equipment, tooling, automation, and process enhancements to support operational objectives.
• Lead equipment qualification and validation activities, including IQ, OQ, and PQ.
• Partner with R&D and Product Development teams to ensure designs are manufacturable, scalable, and aligned with production capabilities.
• Conduct DOE, SPC, MSA, and capability studies to support robust manufacturing processes.
• Support technology transfer, scale-up activities, and new product introductions.
• Ensure compliance with FDA QSR, ISO 13485, GMP, and internal quality requirements.
• Lead risk assessments using FMEA, Fault Tree Analysis, and other risk management tools.
• Support nonconformance investigations, CAPA, engineering changes, and continuous improvement initiatives.

Skills

Lean Manufacturing

Six Sigma

Design of Experiments (DOE)

Statistical Process Control (SPC)

Measurement System Analysis (MSA)

Process Validation (IQ/OQ/PQ)

Quality System Regulations (QSR)

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Minitab

JMP

Power BI

Python

Job description

Medtronic in Matamoros, Mexico, seeks a Manufacturing Engineer to lead development and optimization of production processes for medical technologies, working with Operations, Quality, R&D and Supply Chain to ensure scalable, compliant manufacturing.

You will drive equipment qualification and validation (IQ/OQ/PQ), support technology transfer and new product introductions, and apply Lean/Six Sigma, DOE, SPC, and MSA to improve quality, throughput, and cost performance while complying with FDA