Manufacturing Process Engineer – Lean & Automation

Prc Medtronic Pr Operations Co.; Matamoros; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Medtronic is seeking a manufacturing engineer to lead and optimize production processes for high‑quality medical technologies. You will drive efficiency, quality, and capability improvements in collaboration with Operations, Quality, R&D, and Supply Chain.

The role requires strong experience with DOE, SPC, MSA, IQ/OQ/PQ, and regulatory standards in a fast-paced environment, plus leadership in technology transfers and scale‑ups. On-site in a regulated manufacturing setting.

Qualifications

• Bachelor's degree in Engineering with 4+ years in manufacturing engineering
• Master's degree in Engineering with 2+ years in manufacturing engineering or PhD with 3+ years
• Experience applying Lean Manufacturing and Six Sigma in a regulated manufacturing environment
• Experience with DOE, SPC, MSA, and process capability analysis
• Experience leading equipment qualifications and process validations (IQ/OQ/PQ)
• Knowledge of FDA QSR, ISO 13485, GMP and quality system requirements
• Experience supporting nonconformance investigations, CAPA and engineering changes

Responsibilities

• Lead development, optimization, and sustainment of manufacturing processes to improve quality, efficiency, throughput, and yield
• Drive continuous improvement using Lean Manufacturing and Six Sigma methodologies
• Identify and implement equipment, tooling, automation, and process enhancements
• Lead equipment qualification and validation activities (IQ/OQ/PQ)
• Partner with R&D and Product Development to ensure manufacturability and scalability
• Conduct DOE, SPC, MSA, and capability studies for robust processes
• Support technology transfer, scale-up, and new product introductions
• Ensure compliance with FDA QSR, ISO 13485, GMP and internal quality requirements
• Lead risk assessments using FMEA and other tools
• Support CAPA, engineering changes and continuous improvement initiatives

Skills

Lean Six Sigma

Statistical methods

Process optimization

Project leadership

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Minitab

JMP

Power BI

Python

Job description

Medtronic is seeking a manufacturing engineer to lead and optimize production processes for high‑quality medical technologies. You will drive efficiency, quality, and capability improvements in collaboration with Operations, Quality, R&D, and Supply Chain.

The role requires strong experience with DOE, SPC, MSA, IQ/OQ/PQ, and regulatory standards in a fast-paced environment, plus leadership in technology transfers and scale‑ups. On-site in a regulated manufacturing setting.