Process Engineers - 4 years +

Medtronic•Humacao, PR

About The Position

Join a high-impact manufacturing engineering team responsible for advancing production performance, product quality, and operational excellence. This role partners closely with Operations, Quality, R&D, and Supply Chain to develop, optimize, and scale manufacturing processes that support innovative medical technologies. The engineer will lead strategic process improvements, technology transfers, equipment implementations, and data-driven initiatives that enhance productivity, compliance, and product reliability.

Requirements

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.
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.

Nice To Haves

Lean Six Sigma Green Belt or Black Belt certification.
Experience with automation, digital manufacturing, Industry 4.0, or smart factory technologies.
Experience using Minitab, JMP, Power BI, Python, or other advanced data analytics tools.
Experience with Design for Manufacturability (DFM) and Design for Assembly (DFA) in partnership with R&D teams.
Experience leading technology transfer, process scale-up, and new product introduction projects.
Experience with supplier process development, qualification, and performance improvement initiatives.
Project management experience, including cross-functional leadership of technical initiatives.
Experience mentoring junior engineers and providing technical leadership across teams.
Strong technical writing skills for protocols, validation reports, and regulatory documentation.
Demonstrated success driving cost reduction, value engineering, and operational excellence initiatives.

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 Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Partner with R&D and Product Development teams to ensure designs are manufacturable, scalable, and aligned with production capabilities.
Conduct process characterization, Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (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 Quality System Regulations (QSR), ISO 13485, Good Manufacturing Practices (GMP), and internal quality requirements.
Lead risk assessments using Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis, and other risk management tools.
Support nonconformance investigations, Corrective and Preventive Actions (CAPA), engineering changes, and continuous process improvement initiatives.