Principal Manufacturing Engineer (MES)

TL;DR

Principal Manufacturing Engineer (MES): Designing, deploying, and optimizing Manufacturing Execution Systems (MES) to drive operational excellence and regulatory traceability with an accent on system architecture and ERP integration. Focus on implementing DMAIC methodologies, conducting IQ/OQ/PQ validation protocols, and ensuring compliance with GMP and 21 CFR Part 11 standards.

Location: Onsite in Danvers, Massachusetts, USA. Relocation assistance is not available.

Salary: $148,000 – $184,800 per year

Company

Global leader in medical technology and healthcare solutions.

What you will do

• Drive operational excellence by designing, developing, and optimizing the Manufacturing Execution System (MES).
• Define MES architecture, configure workflows, and implement data models for integration with ERP and quality systems.
• Conduct studies on cost reduction, Return on Investment (ROI), and inventory control.
• Ensure regulatory compliance with GMP and 21 CFR Part 11 through audits and system controls.
• Execute IQ/OQ/PQ system validation protocols to ensure production line compliance.
• Utilize DMAIC problem-solving methodologies to enhance system efficiency and performance.

Requirements

• Bachelor’s degree in Electronic Engineering, Mechanical Engineering, or a related field.
• Minimum 5 years of experience as a systems, electronics, or mechanical engineer.
• Proven expertise in MES architecture, workflow definition, and ERP integration.
• Experience conducting testing, validation, and implementing controls for regulatory compliance.
• Proficiency in DMAIC methodologies and digital manufacturing documentation.
• Experience conducting IQ/OQ/PQ validation protocols.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Health Savings Account (HSA) and Healthcare Flexible Spending Account.
• Paid time off, paid holidays, and short-term/long-term disability leave.
• Employee Stock Purchase Plan and Tuition assistance/reimbursement.
• Global well-being program (Simple Steps).