Senior Process Engineer – Lean, Validation & Tech Transfer

PRC Medtronic Puerto Rico Operations Co. (Puerto Rico Branch)

Humacao (PR)

In loco

USD 90.000 - 130.000

Tempo pieno

7 giorni fa

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Descrizione del lavoro

Medtronic is seeking a manufacturing engineer to lead development, optimization, and sustainment of processes for high-quality medical technologies. You will partner with R&D and Product Development to ensure manufacturability and scale-up, while driving continuous improvement across quality, efficiency, and yield.

The role requires Lean Six Sigma experience in regulated environments, and strong data analytics skills with DOE/SPC/MSA.

Competenze

Senior Level Bachelor's degree in Engineering with 4+ years manufacturing engineering experience OR Master's with 2+ years OR PhD in Engineering.
Principal Level Bachelor's degree in Engineering with 7+ years manufacturing engineering experience OR Master's with 5+ years OR PhD with 3+ years.
Experience applying Lean Manufacturing and Six Sigma in regulated manufacturing environments.
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, and engineering changes.

Mansioni

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 to ensure designs are manufacturable and scalable.
Conduct DOE, SPC, MSA, and capability studies to support robust manufacturing processes.
Support technology transfer, scale-up activities, and new product introductions into manufacturing.
Ensure compliance with FDA QSR, ISO 13485, GMP, and internal quality requirements.
Lead risk assessments using FMEA and other risk management tools.
Support nonconformance investigations, CAPA, engineering changes, and continuous improvement.