Principal Manufacturing Engineer
Core
Design, develop, deploy, operate, and optimize the Manufacturing Execution System (MES) to drive operational excellence and regulatory compliance in medical device manufacturing.
Role type
Principal Manufacturing Engineer (MES)
Builds
MES architecture, workflows, and integrations with ERP and quality systems
Domain
Medical device manufacturing / Digital Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
MES architecture and configuration, ERP integration, GMP and 21 CFR Part 11 compliance, IQ/OQ/PQ validation protocols, DMAIC problem solving, cost reduction and ROI analysis, inventory control, digital manufacturing documentation
Preferred skills
None stated
Technologies
MES, ERP
Responsibilities
Define MES architecture and workflows; Conduct cost reduction and ROI studies; Ensure regulatory compliance via audits and controls; Monitor and optimize MES system performance; Develop digital manufacturing documentation; Execute IQ/OQ/PQ validation protocols
Seniority
Principal, hands-on IC
