Principal Manufacturing Engineer

Medtronic • Cherry Hill, MA

15h • Onsite

About The Position

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.

Requirements

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

Nice To Haves

• The position qualifies for the Medtronic Employee Referral Bonus Program at the level of $1,000.

Responsibilities

• Driving operational excellence by ensuring the successful design, development, deployment, operation, and optimization of the Manufacturing Execution System (MES).
• Conducting various studies pertaining to cost reduction, Return on Investment (ROI), inventory control and production record systems.
• Defining Manufacturing Execution System (MES) architecture, configuration, and implementation of MES workflows to support production operations and regulatory traceability.
• Defining Standard Operating Procedure (SOP) and data models linking MES with ERP (Enterprise Resource Planning) and other Manufacturing and quality systems within the manufacturing environment.
• Complying 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.
• Monitoring performance of the MES system to ensure efficiency by analyzing system metrics, identifying areas for optimization and implementing system enhancements.
• Applying DMAIC (Design, Measure, Analyze, Improve, and Control) problem solving methodologies.
• Developing and maintaining digital manufacturing documentation, including work instructions and process maps, within the MES framework.
• Conducting 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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal