Manufacturing Engineer
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.