Senior Process Engineer, Medical Device Manufacturing

Medtronic; Puerto Rico; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medtronic Incentive Plan

Competitive benefits

Job summary

Medtronic is seeking an experienced Manufacturing Engineer to lead the development and optimization of production processes for advanced medical technologies. You will work closely with Operations, Quality, R&D, and Supply Chain to drive efficiency, quality, and reliability across manufacturing operations.

The role requires expertise in Lean Six Sigma, DOE, SPC, MSA, and equipment qualification (IQ/OQ/PQ) within regulated environments.

Qualifications

• Senior Level Bachelor's degree in Engineering and 4+ years of manufacturing engineering experience OR Master's degree in Engineering and 2+ years of manufacturing engineering experience OR PhD in Engineering.
• Principal Level Bachelor's degree in Engineering and 7+ years of manufacturing engineering experience OR Master's degree in Engineering and 5+ years of manufacturing engineering experience OR PhD in Engineering and 3+ years of manufacturing engineering experience.
• Experience applying Lean Manufacturing and Six Sigma methodologies in a regulated manufacturing environment.

Responsibilities

• Lead the development, optimization, and sustainment of manufacturing processes to improve quality, efficiency, throughput, and yield.
• Drive continuous improvement initiatives 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 and scalable.
• Conduct process characterization, DOE, SPC, MSA, and capability studies to support robust manufacturing processes.
• Support technology transfer, scale-up activities, and new product introductions, ensuring successful transition into manufacturing operations.
• Ensure compliance with FDA QSR, ISO 13485, GMP, and internal quality requirements.

Skills

Lean Manufacturing

Six Sigma

DOE

SPC

MSA

IQ/OQ/PQ

Regulated environment

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 an experienced Manufacturing Engineer to lead the development and optimization of production processes for advanced medical technologies. You will work closely with Operations, Quality, R&D, and Supply Chain to drive efficiency, quality, and reliability across manufacturing operations.

The role requires expertise in Lean Six Sigma, DOE, SPC, MSA, and equipment qualification (IQ/OQ/PQ) within regulated environments.