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Principal Manufacturing Engineer

Medtronic

Lafayette, CO, US$123k – $185konsite

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About this role

We anticipate the application window for this opening will close on - 15 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life At Medtronic Neuroscience, we are redefining what's possible in neurological and spinal care, bringing together innovation, expertise, and partnership to improve lives around the world.

At Medtronic ENT, we deliver innovative technologies that help clinicians treat complex ear, nose, and throat conditions with greater precision and confidence. Our solutions enhance patient outcomes across both office and surgical settings.                     This person will be responsible for driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES). Conduct various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems. Define Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability. Define Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment. Comply with Medical industry standards system testing and validation according to Good Manufacturing Practices (GMP), 21 CFR Part 11 requirements, regulations and quality mgmt. requirements by conducting audits and implementing controls to ensure regulatory compliance. Monitor performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements. Apply DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies. Develop and maintain digital manufacturing documentation, including work instructions and process maps, within the MES framework. Conduct Installation Qualification, Operational Qualification, and Performance Qualification (IQ/OQ/PQ) system validation protocols involving test steps per production line to ensure MES compliance with regulations.

Primary Responsibilities: • Lead the implementation, enhancement, and ongoing support of Manufacturing Execution Systems (MES) to improve manufacturing performance, quality, compliance, and operational efficiency.

• Partner with Operations, Manufacturing, Quality, Engineering, and IT teams to design, optimize, and deploy digital manufacturing solutions.

• Develop and maintain manufacturing workflows, system configurations, work instructions, and technical documentation to support business processes.

• Drive continuous improvement initiatives through analysis of manufacturing processes, system performance, and operational data.

• Ensure manufacturing systems comply with applicable regulatory requirements and internal quality standards.

• Support system validation activities, including protocol development, testing, documentation, and change control processes.

• Manage complex cross-functional projects related to manufacturing systems, automation, and process improvements.

• Provide technical leadership and subject matter expertise for MES architecture, system integration, and manufacturing technologies.

• Train and mentor users on manufacturing systems, processes, and best practices.

• Collaborate with stakeholders to identify business needs and translate requirements into scalable manufacturing solutions.

Required Qualifications: • Bachelor's degree in Engineering, Manufacturing Engineering, Industrial Engineering, Computer Science, Information Systems, or related technical field.

• 7+ years of experience in manufacturing engineering, manufacturing systems, digital manufacturing, MES, or related technical disciplines.

• Experience implementing, supporting, or optimizing Manufacturing Execution Systems (MES) in a regulated manufacturing environment.

• Experience working with ERP, quality, and manufacturing systems integrations.

• Knowledge of manufacturing process controls, quality systems, and regulatory requirements, including GMP and 21 CFR Part 11.

• Experience supporting software validation and qualification activities within regulated industries.

Preferred Qualifications: • Advanced degree in Engineering, Manufacturing, Operations, or related field.

• Medical device, pharmaceutical, biotech, or other highly regulated industry experience.

• Experience with MES platforms such as Tulip, Camstar, Opcenter, FactoryTalk, PAS-X, or similar solutions.

• Experience with electronic batch records (EBR) or electronic device history records (eDHR).

• Lean Manufacturing, Six Sigma Green Belt/Black Belt, or equivalent continuous improvement certification.

• Experience supporting digital transformation, Industry 4.0, smart factory, or connected manufacturing initiatives.

• Experience developing manufacturing dashboards, KPIs, and data analytics solutions.

• Project Management certification (PMP) or equivalent project leadership experience.

• Experience supporting internal, customer, or regulatory audits.

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands des

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