Industrial Engineer on W2 Only

Location: Chappells
Posted on: June 23, 2025

Job Description:

Client : EASI Title : Industrial Engineer Location : Sumter, SC Duration : 12 Months Rate : $Open Visa Status : Any work Status On W2 Only Relevant Experience: 8 Years 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 Work Environment This position is onsite in Sumter, SC. The role involves working within a regulated manufacturing environment, ensuring compliance with industry standards and regulations. The candidate will have access to modern technologies and equipment, with a focus on process improvement and optimization. Benefits include 2 weeks of PTO and 6 paid holidays. Regards, Shanthi Pedhiredla SOVEREIGN TECHNOLOGIES LLC Desk no - (636) 410-0680 4 Direct no - ((636) 410-0678) pshanthi@sovereigntec.com http://www.sovereigntec.com Certified Minority Owned Business ( MBE)

Keywords: , Rock Hill , Industrial Engineer on W2 Only, Engineering , Chappells, South Carolina