Industrial Engineer

Roles & Responsibilities

• Analise and improve manufacturing workflows, assembly processes, and equipment utilization for medical device production.

• Develop and implement process optimization strategies while ensuring compliance with FDA regulations, ISO 13485, and GMP (Good Manufacturing Practices) .

• Conduct time studies, capacity analysis, and line balancing to improve efficiency and reduce waste.

• Collaborate with Quality Assurance to ensure processes meet stringent quality and validation requirements.

• Support Design for Manufacturability (DFM) during new product introduction and scale-up.

• Drive autonomation initiatives, digitization and integration of advanced technologies to improve precision and consistency. Hands on experience in Karakuri will be an advantage

• Monitor KPIs such as yield, cycle time, and cost per unit; implement corrective actions as needed.

• Lead continuous improvement projects using Lean, Six Sigma, and Kaizen methodologies.

• Develop Value Stream by minimizing NVA processes. Well versed with production planning, monitoring

• Ensure compliance with health, safety, and environmental standards in all operations.

Qualifications & Skills:

• Education: Bachelor s degree in industrial engineering.

• Experience: 7-12 years in manufacturing or other regulated industries (pharma, biotech, Automotive).

• Technical Skills:

  • Knowledge of FDA 21 CFR Part 11 , ISO 13485, and GMP requirements.

  • Proficiency in CAD tools, simulation software, and ERP systems.

  • Expertise in Lean Manufacturing and Six Sigma methodologies.

• Soft Skills: Strong analytical ability, problem-solving, communication, and project management skills.

Preferred Certifications:

• Lean Six Sigma Green Belt or Black Belt

• ASQ Certified Quality Engineer (CQE)

• Experience with Industrial engineering skills