Industrial Engineer (W2)

Job Title: Industrial Engineer

Location: Sumter, SC

Job Description

We are seeking a detail-oriented and innovative Industrial Engineer to lead process optimization initiatives within our medical device manufacturing operations. This role is critical in ensuring that our production lines meet the highest standards of efficiency, quality, and regulatory compliance. The ideal candidate will bring a strong background in lean manufacturing, process validation, and continuous improvement within a regulated environment.

Responsibilities

• Analyze and optimize manufacturing workflows to improve efficiency, reduce waste, and ensure compliance with FDA and other regulatory standards.
• Lead time studies, line balancing, and capacity analysis to support production planning and scalability.
• Design and implement lean manufacturing solutions, including 5S, value stream mapping, and visual management systems.
• Collaborate with Quality Assurance and Regulatory Affairs to ensure all process changes are validated and documented per GMP requirements.
• Develop and maintain detailed process documentation, including work instructions, PFMEAs, control plans, and validation protocols (IQ/OQ/PQ).
• Support new product introductions (NPIs) by designing efficient, compliant manufacturing processes and participating in design for manufacturability (DFM).
• Lead root cause investigations and corrective/preventive actions (CAPAs) for process deviations and non-conformances.
• Evaluate and implement new technologies and automation solutions to enhance precision, traceability, and throughput.
• Facilitate cross-functional kaizen events and continuous improvement workshops.
• Monitor and report on key performance indicators (KPIs) such as yield, cycle time, OEE, and defect rates.
• Ensure ergonomic and safety standards are integrated into all process designs.
• Support audits and inspections by providing technical documentation and process insights.

Essential Skills

• Industrial engineering
• Manufacturing engineering
• Process improvement
• Continuous improvement
• Lean manufacturing
• Time studies
• Regulated manufacturing
• Process validation
• Knowledge of FDA 21 CFR 820 and GMP requirements

Additional Skills & Qualifications

• Bachelor s degree in Industrial Engineering, Manufacturing Engineering, or a related field
• 3+ years of experience in a regulated manufacturing environment, must be medical devices or pharmaceuticals
• Proficiency in CAD software, statistical analysis tools (e.g., Minitab), and ERP/MES systems
• Excellent analytical, documentation, and communication skills
• Experience with cleanroom manufacturing and sterile packaging is a plus
• Lean Six Sigma Green Belt or Black Belt certification
• Certified Quality Engineer (CQE) or Certified Manufacturing Engineer (CMfgE)
• PMP (Project Management Professional) Certification