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Key Responsibilities:

  • Drive Lean improvements to increase yield, efficiency, and throughput.
  • Lead root cause investigations and CAPA implementation activities.
  • Support process transfer and scale-up from development into production.
  • Execute process qualification (PQ) and assess production readiness.
  • Develop and improve SOPs, work instructions, and process documentation.
  • Collaborate with customers, Quality, Operations, and R&D while ensuring ISO 13485/GMP compliance.

Education & Qualifications:

  • Bachelor’s degree in Mechanical, Manufacturing, Industrial Engineering, or related field.
  • 2–7 years of manufacturing or process engineering experience.
  • Background in regulated industries, preferably medical devices.
  • Experience applying Lean manufacturing principles and continuous improvement.
  • Strong troubleshooting, root cause analysis, and communication skills.
  • Familiarity with cleanroom environments and production support.
  • Knowledge of process validation, GMP, ISO 13485, and CAD/CAM tools preferred.