Senior Manufacturing Engineer

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.