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.
