Principal Manufacturing Engineer at MDU Medtronic USA Inc — Danvers, MA

We anticipate the application window for this opening will close on - 7 Sep 2026

Position Description:

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. Relocation assistance not available for this position. #LI-DNI

Basic Qualifications:

Bachelor’s Degree or foreign equivalent in Electronic Engineering, Electronics & Instrumentation, Mechanical Engineering, or related engineering field and five (5) years of progressively responsible experience as a systems engineer, electronics engineer, or mechanical engineer. Must possess at least 5 years’ experience with each of the following: Conducting studies pertaining to cost reduction, ROI, inventory control and production record systems; MES architecture, defining workflows, configuring user interfaces, and integrating with ERP; Conducting Testing, Validation and implementing controls for regulatory compliance; Monitoring, optimizing, and implementing enhancements of MES systems; DMAIC; Developing and maintaining Digital manufacturing Documentation; and Conducting IQ/OQ/PQ system validation protocols involving test steps per production line for MES compliance with regulations.

Salary: $148,000 to $184,800 per year

Recruitment Fraud Alert We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

Medtronic will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.

If you suspect you have received a fraudulent offer or communication claiming to be from Medtronic, please do not respond, open any attachments, or click on any hyperlinks.