Industrial Engineer
Kasmo Global
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
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.
- 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
- 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
- Lean Six Sigma Green/Black Belt
- Certified Quality Engineer (CQE)
- Certified Manufacturing Engineer (CMfgE)
- PMP Certification
Vacancy posted 4 days ago
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