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Senior Manufacturing Engineer

Katalyst Healthcares and Life Sciences

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.
Vacancy posted 1 day ago
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