Senior Manufacturing Engineer

About the Role

The Senior Manufacturing Engineer develops, implements, and optimizes manufacturing processes to improve efficiency, quality, and cost-effectiveness while ensuring compliance with ISO 9001, ISO 13485, and FDA standards.

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, including PFMEA, IQ, TMV, OQ/PQ, and statistical analysis of process data.
• 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.

Requirements

• 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 and project management activities.
• Basic understanding of business processes and Operational Excellence, including Lean Manufacturing and problem-solving methodologies.
• Proficiency with SAP, Power Apps, Windchill, PDF Writer, and MS Office.