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Senior Manufacturing Engineer

Katalyst Healthcares & Life Sciences

  • Round Lake, IL
  • 12 days ago

    Highlights

    Job Summary: The Senior Manufacturing Engineer will be responsible for developing, implementing, and optimizing manufacturing processes to improve efficiency, quality, and cost-effectiveness. Manage and document process deviations, corrective actions, and improvements through SICR (Supplier/Internal Corrective Reports).

    Numbers & Facts

    LocationRound Lake, IL

    Description

    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.

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