Industrial Engineer

Position OverviewWe are seeking an experienced Industrial Engineer with a strong background in the Medical Device and Pharmaceutical manufacturing environment. The role involves optimizing production processes, improving efficiency, and ensuring compliance with regulatory standards (FDA, cGMP, ISO 13485).Key ResponsibilitiesAnalyze and improve production workflows, equipment layouts, and manufacturing processes to enhance efficiency and quality.Conduct time and motion studies, capacity analysis, and process mapping.Implement Lean, Six Sigma, and continuous improvement methodologies to reduce waste and variability.Collaborate with cross-functional teams (Manufacturing, Quality, Supply Chain, R&D).Support validation and documentation activities (process validation, equipment qualification).Develop and maintain standard operating procedures (SOPs) and work instructions.Monitor key performance metrics (OEE, throughput, defect rates) and identify improvement opportunities.Participate in new product introduction (NPI) and process scale-up activities.Ensure all improvements meet FDA, cGMP, and ISO compliance requirements.QualificationsBachelor’s or Master’s degree in Industrial Engineering, Manufacturing Engineering, or related discipline.2–5 years of experience in Medical Device or Pharmaceutical manufacturing environments.Strong understanding of Lean Manufacturing, Six Sigma, and process optimization tools.Experience with process validation, risk assessment, and documentation.Familiarity with ERP/MES systems (SAP, Oracle, etc.) preferred.Excellent communication, analytical, and problem-solving skills.Preferred CertificationsLean Six Sigma Green Belt or higherKnowledge of FDA, cGMP, ISO 13485, and 21 CFR Part 820 regulations