Senior Manufacturing Engineer — Lean Process Optimizer

JobDiva, Inc.; Round Lake (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

JobDiva, Inc. in Illinois is seeking a Senior Manufacturing Engineer to develop, implement, and optimize manufacturing processes that boost efficiency, quality, and cost-effectiveness on our production lines.

You will lead FAI, manage QN in SAP, document deviations and CAPA, and collaborate with Quality, R&D, Supply Chain, and Production to drive Lean and Six Sigma improvements while ensuring ISO 9001, ISO 13485, and FDA compliance.

Qualifications

• BS/BA degree in management, operations, engineering, or related field.
• 8+ years in senior manufacturing engineering.
• Experience with PFMEA, IQ, OQ/PQ, and statistical analysis.
• GD&T on mechanical drawings.
• Experience in process validation and CAPA.

Responsibilities

• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection (FAI) activities to ensure conformance.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances.
• Manage process deviations and corrective actions through SICR.
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve issues.
• Analyze manufacturing data and drive continuous improvement using Lean and Six Sigma.
• Support root cause analysis and CAPA implementation.
• Ensure compliance with ISO 9001, ISO 13485, and FDA standards.
• Host meetings, document actions, track due dates, and monitor progress.
• Communicate with Project Leads to align projects with goals.
• Utilize Power Apps, Windchill, PDF Writer, and MS Office daily.

Skills

Lean Manufacturing

Six Sigma

Root cause analysis

Project management

GD&T

CAPA

Process validation

Cross-functional collaboration

Education

BS/BA in Management, Operations, Engineering, or related field

Tools

SAP

Power Apps

Windchill

MS Office

PDF Writer

Job description

JobDiva, Inc. in Illinois is seeking a Senior Manufacturing Engineer to develop, implement, and optimize manufacturing processes that boost efficiency, quality, and cost-effectiveness on our production lines.

You will lead FAI, manage QN in SAP, document deviations and CAPA, and collaborate with Quality, R&D, Supply Chain, and Production to drive Lean and Six Sigma improvements while ensuring ISO 9001, ISO 13485, and FDA compliance.