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Medtronic

Medical device maker advancing therapies

Process Engineers - 4 years +

Manufacturing EngineeringUpdated on Nov 3
Full-timeHumacao, Puerto RicoIn-person

About the Job

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 Design of Experiments (DOE), Statistical Process Control (SPC), Measurement System Analysis (MSA), and process capability analysis.
  • Experience leading equipment qualifications and process validations (IQ/OQ/PQ).
  • Knowledge of FDA Quality System Regulations (QSR), ISO 13485, Good Manufacturing Practices (GMP), and quality system requirements.
  • Experience supporting nonconformance investigations, Corrective and Preventive Action (CAPA) activities, and engineering change implementation.
  • For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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 Research and Development 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.

Desired Qualifications

  • 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 Research and Development 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.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

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