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Senior Manufacturing Engineer

Karwell Technologies

  • Cambridge, MA
  • 5 days ago
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    Skills

    • Adobe Acrobatunmatched
    • Assembly Lineunmatched
    • Business Processesunmatched
    • Continuous Improvementunmatched
    • Corrective Actionunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cost Effectiveness Analysisunmatched
    • Data Analysisunmatched
    • Document Managementunmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • Failure Analysisunmatched
    • Geometric Dimensioning and Tolerancingunmatched
    • ISO (International Organization for Standardization)unmatched
    • ISO 9001unmatched
    • Identify Issuesunmatched
    • Industry Standardsunmatched
    • Inventory Reportsunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Maintain Complianceunmatched
    • Manufacturing Analysisunmatched
    • Manufacturing Engineeringunmatched
    • Manufacturing/Industrial Processesunmatched
    • Materials Managementunmatched
    • Microsoft Officeunmatched
    • Problem Solving Skillsunmatched
    • Process Analysisunmatched
    • Process Failure Mode and Effects Analysis (PFMEA)unmatched
    • Process Improvementunmatched
    • Process Managementunmatched
    • Process Validationunmatched
    • Product Designunmatched
    • Production Planningunmatched
    • Production Supportunmatched
    • Project Trackingunmatched
    • Project/Program Managementunmatched
    • Quality Managementunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Root Cause Analysisunmatched
    • SAPunmatched
    • Safety Trainingunmatched
    • Set Goalsunmatched
    • Statisticsunmatched
    • Supply Chainunmatched
    • Validation Documentationunmatched
    • Windchill PLM Softwareunmatched
    • Writing Skillsunmatched

    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.

    Numbers & Facts

    LocationCambridge, MA

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