What are the responsibilities and job description for the Senior Manufacturing Engineer position at Katalyst CRO?
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.
- 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.
- 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.