Senior Process Engineer - Lean Manufacturing & Validation

Medtronic; Humacao, Northern (PR, KY); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medtronic Incentive Plan

Competitive benefits

Job summary

Medtronic Humacao, PR is seeking a Senior Process Engineer to lead the development, optimization, and sustainment of medical device manufacturing processes. The role partners with Operations, Quality, R&D, and Supply Chain to implement data-driven improvements and scale production while maintaining strict regulatory compliance.

The ideal candidate has 4+ years of manufacturing engineering experience with Lean/Six Sigma experience in regulated environments, strong statistics skills (DOE/SPC/MSA),

Qualifications

• 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.
• Experience applying Lean Manufacturing and Six Sigma methodologies in a regulated manufacturing environment.
• Experience with advanced statistical tools, including 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 activities, and engineering change implementation.

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, scalable, and aligned with production capabilities.
• 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.
• Lead risk assessments using FMEA, Fault Tree Analysis, and other risk management tools.
• Support nonconformance investigations, CAPA, engineering changes, and continuous process improvement initiatives.

Skills

Lean Manufacturing

Six Sigma

DOE

SPC

MSA

Process Capability

Education

Bachelor's degree in Engineering

Master's degree in Engineering

PhD in Engineering

Tools

Minitab

JMP

Power BI

Python

Job description

Medtronic Humacao, PR is seeking a Senior Process Engineer to lead the development, optimization, and sustainment of medical device manufacturing processes. The role partners with Operations, Quality, R&D, and Supply Chain to implement data-driven improvements and scale production while maintaining strict regulatory compliance.

The ideal candidate has 4+ years of manufacturing engineering experience with Lean/Six Sigma experience in regulated environments, strong statistics skills (DOE/SPC/MSA),