Industrial Engineer

Kasmo Global

Sumter, SC

JOB DETAILS
SKILLS
Analysis Skills, Automation, Biotech and Pharmaceutical, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Capacity Analysis, Certified Quality Engineer (CQE), Code of Federal Regulations, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Detail Oriented, Documentation, ERP (Enterprise Resource Planning), Ergonomics, External Audit, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Industrial Engineering, Internal Audit, Lean Manufacturing, Lean Six Sigma, Line Balancing, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing Design, Manufacturing Engineering, Medical Equipment, Minitab, Performance Metrics, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Validation, Product Support, Product/Service Launch, Production Planning, Production Support, Project Management Professional (PMP), Root Cause Analysis, Safety Standards, Six Sigma Black Belt, Six Sigma Green Belt, Standard Operating Procedures (SOP), Technical Writing, Traceability, Trend Analysis, Value Stream Mapping
LOCATION
Sumter, SC
POSTED
Today
Job Title: Industrial Engineer
Duration: 12 Months


Position Overview

We are seeking a detail-oriented and innovative Industrial Engineer to lead process optimization efforts within a regulated medical device manufacturing environment. This role is critical to improving production efficiency, supporting compliance, and implementing lean methodologies for sustainable operational excellence.

Key Responsibilities
  • Analyze and optimize manufacturing workflows to enhance efficiency and reduce waste while ensuring compliance with FDA 21 CFR 820 and GMP standards.
  • Conduct time studies, line balancing, and capacity analysis to support production planning and process scalability.
  • Design and implement Lean Manufacturing initiatives (5S, Value Stream Mapping, Visual Management).
  • Lead process validation activities including IQ/OQ/PQ and ensure thorough documentation of all changes.
  • Develop and maintain process documentation (PFMEA, control plans, SOPs, work instructions).
  • Support New Product Introductions (NPIs) by collaborating on Design for Manufacturability (DFM) and efficient line setups.
  • Drive root cause investigations and CAPA processes for deviations and non-conformances.
  • Evaluate and implement new automation and technology solutions to improve throughput, traceability, and product quality.
  • Lead kaizen events and continuous improvement workshops across cross-functional teams.
  • Monitor KPIs such as cycle time, yield, OEE, and defect rates to identify trends and drive improvements.
  • Ensure ergonomics and safety standards are incorporated in all process designs.
  • Support internal and external audits and inspections with technical documentation and process expertise.
Essential Skills
  • Industrial/Manufacturing Engineering
  • Lean Manufacturing & Continuous Improvement
  • Process Validation (IQ/OQ/PQ)
  • FDA 21 CFR 820 / GMP Compliance
  • Time & Motion Studies, Root Cause Analysis
  • Documentation & Process Mapping
Qualifications
  • Bachelor's degree in Industrial or Manufacturing Engineering (or related field)
  • 3+ years of experience in regulated manufacturing (preferably medical device or pharmaceutical)
  • Proficient with CAD, Minitab, and ERP/MES platforms
  • Strong analytical, communication, and documentation skills
Preferred Certifications
  • Lean Six Sigma Green/Black Belt
  • Certified Quality Engineer (CQE)
  • Certified Manufacturing Engineer (CMfgE)
  • PMP Certification

About the Company

K

Kasmo Global