Manufacturing Process Engineer: Lean, GMP & Tech Transfer

Medtronic plc; United States; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Short-term incentive (MIP)

Job summary

Medtronic plc is seeking an experienced Manufacturing Engineer to drive development and optimization of production processes across R&D, Operations, and Quality. You will lead equipment qualifications, data-driven improvements, and scalable manufacturing initiatives for medical technologies.

The role emphasizes Lean Six Sigma, DOE, SPC, MSA, and regulatory compliance to ensure high-quality, reliable production.

Qualifications

• Bachelor's degree in Engineering and 4+ years of manufacturing engineering experience (Senior)
• Master's degree in Engineering and 2+ years of manufacturing engineering experience (Senior)
• PhD in Engineering with related experience (Senior/Principal)
• Experience applying Lean Manufacturing and Six Sigma in regulated manufacturing environments
• Experience with advanced statistical tools (DOE, SPC, MSA, capability analysis)
• Experience leading equipment qualifications and process validations (IQ/OQ/PQ)

Responsibilities

• Lead development, optimization, and sustainment of manufacturing processes to improve quality, throughput, and yield
• Drive continuous improvement using Lean, Six Sigma, and statistics
• Identify and implement equipment, tooling, automation, and process enhancements
• Lead equipment qualification and validation activities (IQ/OQ/PQ)
• Collaborate 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 (FMEA, Fault Tree) and CAPA activities
• Support nonconformance investigations and engineering changes

Skills

Lean Manufacturing

Six Sigma

DOE

SPC

MSA

FMEA

CAPA

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Minitab

JMP

Power BI

Python

Job description

Medtronic plc is seeking an experienced Manufacturing Engineer to drive development and optimization of production processes across R&D, Operations, and Quality. You will lead equipment qualifications, data-driven improvements, and scalable manufacturing initiatives for medical technologies.

The role emphasizes Lean Six Sigma, DOE, SPC, MSA, and regulatory compliance to ensure high-quality, reliable production.