Industrial Engineer on W2 Only Position Available In Newberry, South Carolina

Job Description:

Client :

EASI Title :

Industrial Engineer Location :

Sumter, SCDuration :

12

Months Rate :

$

Open Visa Status :

Any work Status OnW2

Only Relevant Experience:

8 Years Job Description We are seekinga detail-oriented and innovative Industrial Engineer to leadprocess optimization initiatives within our medical devicemanufacturing operations. This role is critical in ensuring thatour production lines meet the highest standards of efficiency,quality, and regulatory compliance. The ideal candidate will bringa strong background in lean manufacturing, process validation, andcontinuous improvement within a regulated environment.

Responsibilities Analyze and optimize manufacturing workflows toimprove efficiency, reduce waste, and ensure compliance with FDAand other regulatory standards. Lead time studies, line balancing,and capacity analysis to support production planning andscalability. Design and implement lean manufacturing solutions,including 5S, value stream mapping, and visual management systems.

Collaborate with Quality Assurance and Regulatory Affairs to ensureall process changes are validated and documented per GMPrequirements. Develop and maintain detailed process documentation,including work instructions, PFMEAs, control plans, and validationprotocols (IQ/OQ/PQ). Support new product introductions (NPIs) bydesigning efficient, compliant manufacturing processes andparticipating in design for manufacturability (DFM). Lead rootcause investigations and corrective/preventive actions (CAPAs) forprocess deviations and non-conformances. Evaluate and implement newtechnologies and automation solutions to enhance precision,traceability, and throughput. Facilitate cross-functional kaizenevents and continuous improvement workshops. Monitor and report onkey performance indicators (KPIs) such as yield, cycle time, OEE,and defect rates. Ensure ergonomic and safety standards areintegrated into all process designs. Support audits and inspectionsby providing technical documentation and process insights.

Essential Skills Industrial engineering Manufacturing engineeringProcess improvement Continuous improvement Lean manufacturing Timestudies Regulated manufacturing Process validation Knowledge of

FDA21 CFR

820 and GMP requirements Additional Skills & QualificationsBachelor’s degree in Industrial Engineering, ManufacturingEngineering, or a related field 3 years of experience in aregulated manufacturing environment, must be medical devices orpharmaceuticals Proficiency in CAD software, statistical analysistools (e.g., Minitab), and ERP/MES systems Excellent analytical,documentation, and communication skills Experience with cleanroommanufacturing and sterile packaging is a plus Lean Six Sigma GreenBelt or Black Belt certification Certified Quality Engineer (CQE)or Certified Manufacturing Engineer (CMfgE) PMP (Project ManagementProfessional) Certification Work Environment This position isonsite in Sumter, SC. The role involves working within a regulatedmanufacturing environment, ensuring compliance with industrystandards and regulations. The candidate will have access to moderntechnologies and equipment, with a focus on process improvement andoptimization. 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 CertifiedMinority Owned Business ( MBE)