Senior Manufacturing Engineer

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

Job Summary:

• The Senior Manufacturing Engineer will be responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• The role supports manufacturing production lines, process validation, continuous improvement initiatives, project management activities, and ensures compliance with ISO 9001, ISO 13485, and FDA standards.

Roles & Responsibilities:

• Develop, implement, and optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness.
• Lead and support First Article Inspection (FAI) activities to ensure products meet design and regulatory requirements.
• Create, manage, and track Quality Notifications (QN) in SAP for nonconformances, defects, and process issues.
• Manage and document process deviations, corrective actions, and improvements through SICR (Supplier/Internal Corrective Reports).
• Utilize SAP for production planning, material management, inventory tracking, and reporting.
• Collaborate with Quality, R&D, Supply Chain, and Production teams to resolve issues and improve manufacturing processes.
• Analyze manufacturing data and implement continuous improvement strategies using Lean and Six Sigma methodologies.
• Support root cause analysis and implement corrective and preventive actions (CAPA).
• Ensure compliance with industry standards, safety requirements, ISO 9001, ISO 13485, and FDA regulations.
• Support manufacturing production lines and project management activities.
• Support and execute process validation activities.
• Host daily and weekly meetings, document action items, assign owners, track due dates, and monitor progress.
• Communicate with Project Leads to keep projects aligned with established goals.
• Utilize Power Apps, Windchill, PDF Writer, and MS Office in day-to-day activities.

Education & Experience:

• BS/BA degree in Management, Operations, Engineering, or a closely related field.
• Minimum 8+ years of experience in Senior Manufacturing Engineering.
• Experience in root cause analysis of production process failures and troubleshooting production equipment issues.
• Experience with process validation documentation including PFMEA, IQ, TMV, OQ/PQ, and statistical analysis of process data.
• Understanding of geometric dimensioning and tolerancing (GD&T) on mechanical drawings.
• Knowledge of manufacturing production lines.
• Experience in project management activities.
• Knowledge of process validation.
• Basic understanding of business processes.
• Basic knowledge of Operational Excellence, including Lean Manufacturing and problem-solving methodologies.
• Proficiency with SAP, Power Apps, Windchill, PDF Writer, and MS Office.