Manufacturing Process Engineer

Karwell Technologies
  • Rockford, IL
  • Quick Apply
30+ days ago

Job Description

Job Description:
We are seeking a Manufacturing Process Engineer to support manufacturing operations by developing, optimizing, and validating production processes to improve efficiency, quality, and productivity. The ideal candidate will work closely with Manufacturing, Quality, Operations, R&D, and Supply Chain teams to drive continuous improvement initiatives, resolve production issues, and ensure compliance with safety and regulatory requirements in a fast-paced manufacturing environment.
Roles & Responsibilities:
  • Develop, implement, and optimize manufacturing processes to improve productivity, quality, and cost efficiency.
  • Analyze manufacturing workflows and identify opportunities for process improvements using Lean Manufacturing and Six Sigma methodologies.
  • Support new product introduction (NPI), process development, and technology transfer activities.
  • Design, validate, and document manufacturing processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), where applicable.
  • Investigate production issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
  • Create and maintain process documentation, work instructions, Standard Operating Procedures (SOPs), and manufacturing specifications.
  • Collaborate with cross-functional teams including Manufacturing, Quality Assurance, R&D, Maintenance, Supply Chain, and Regulatory Affairs.
  • Support equipment selection, installation, commissioning, and validation activities.
  • Monitor process performance using statistical tools such as Statistical Process Control (SPC) and process capability analysis.
  • Lead continuous improvement initiatives focused on cycle time reduction, waste elimination, yield improvement, and cost savings.
  • Participate in Failure Mode and Effects Analysis (FMEA), risk assessments, and process validation activities.
  • Support manufacturing scale-up, process transfers, and production line improvements.
  • Ensure compliance with company quality systems, safety procedures, and applicable regulatory requirements including GMP/cGMP, FDA, and ISO standards.
  • Train manufacturing personnel on new processes, equipment, and standardized work procedures.
  • Prepare technical reports, engineering documentation, and project status updates.
Requirements:
  • Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, Biomedical Engineering, or a related engineering discipline.
  • 2 5 years of manufacturing or process engineering experience.
  • Experience supporting manufacturing operations in regulated or high-volume production environments.
  • Knowledge of Lean Manufacturing, Six Sigma, and Continuous Improvement methodologies.
  • Experience with process validation, root cause analysis, and problem-solving techniques.
  • Strong understanding of manufacturing documentation and engineering change processes.
  • Excellent analytical, organizational, and communication skills.
  • Proficiency with Microsoft Office Suite.
Preferred Qualifications:
  • Experience in Medical Device, Pharmaceutical, Biotechnology, Automotive, Aerospace, or Electronics manufacturing.
  • Knowledge of GMP/cGMP, FDA regulations, ISO 13485, ISO 9001, or AS9100.
  • Experience with CAD software (SolidWorks, AutoCAD, Creo, or equivalent).
  • Familiarity with ERP and Manufacturing Execution Systems (MES).
  • Green Belt or Black Belt certification in Lean Six Sigma.
  • Experience with automation, robotics, PLCs, or manufacturing equipment integration.

Numbers & Facts

LocationRockford, IL

Skills

  • Aerospace and Defenseunmatched
  • Analysis Skillsunmatched
  • AutoCADunmatched
  • Automationunmatched
  • Biomedical Engineeringunmatched
  • Biotech and Pharmaceuticalunmatched
  • CAD (Computer-Aided Design) Softwareunmatched
  • Chemical Engineeringunmatched
  • Commissioningunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Corporate Complianceunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cost Controlunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Documentationunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • Electronics Manufacturingunmatched
  • Engineeringunmatched
  • Engineering Change Managementunmatched
  • Equipment Selectionunmatched
  • FDA (Food and Drug Administration)unmatched
  • FDA Requirementsunmatched
  • Failure Mode and Effects Analysis (FMEA)unmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 9001unmatched
  • Industrial Engineeringunmatched
  • Lean Manufacturingunmatched
  • Lean Six Sigmaunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Analysisunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Equipmentunmatched
  • Manufacturing Execution Systems (MES)unmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Process Engineeringunmatched
  • Manufacturing Requirementsunmatched
  • Manufacturing/Industrial Processesunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Microsoft Officeunmatched
  • Operational Supportunmatched
  • Organizational Skillsunmatched
  • PTC Creounmatched
  • Performance Analysisunmatched
  • Problem Solving Skillsunmatched
  • Process Analysisunmatched
  • Process Capabilityunmatched
  • Process Developmentunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Product Supportunmatched
  • Product/Service Launchunmatched
  • Production Systemsunmatched
  • Production Volumeunmatched
  • Productivity Managementunmatched
  • Programmable Logic Controller (PLC)unmatched
  • Quality Assuranceunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Reporting Skillsunmatched
  • Research & Development (R&D)unmatched
  • Risk Analysisunmatched
  • Roboticsunmatched
  • Root Cause Analysisunmatched
  • Safety Complianceunmatched
  • Safety Processunmatched
  • Six Sigma Black Beltunmatched
  • Six Sigma Certificationunmatched
  • Six Sigma Green Beltunmatched
  • SolidWorksunmatched
  • Staff Trainingunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Statistical Process Controlunmatched
  • Supply Chainunmatched
  • Time Managementunmatched
  • Workflow Analysisunmatched

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