Department: Operations / Manufacturing Engineering

Location: Chennai, India (Medical Device CDMO Facility)

Reports To: Head Manufacturing / Operations Manager

Role Purpose

Responsible for establishing, validating, and continuously improving sheet metal manufacturing processes for medical device components. Ensures processes are capable, compliant, cost-effective, and meet customer and regulatory requirements.

Key Responsibilities

- Own and control sheet metal fabrication, bending, welding, finishing, and assembly processes.
- Maintain process flow diagrams (PFD), PFMEA, control plans, and work instructions.
- Lead IQ/OQ/PQ activities for new and modified processes.
- Conduct process capability studies and DOE for critical parameters.
- Implement Lean, Six Sigma, Kaizen, and 5S initiatives to improve efficiency.
- Coordinate with Design, QA, Supply Chain, and Maintenance teams for end-to-end process performance.
- Ensure ISO 13485, FDA QSR, and MDR compliance in all process activities.

Required Skills & Competencies

- Expertise in Laser Cutting, CNC Bending,



TIG/MIG Welding, Riveting, and Surface Finishing.
- Knowledge of PFMEA, Control Plans, DOE, MSA, SPC, and PPAP methodologies.
- Understanding of ISO 13485, 21 CFR 820, EU MDR compliance requirements.
- Hands-on CAD/CAM knowledge (AutoCAD, SolidWorks, NX).
- Robust analytical and problem-solving skills using Root Cause Analysis and DMAIC.
- Experience in ERP/MES systems for production tracking and process validation.

Education & Experience

- B.E./B.Tech in Mechanical / Industrial / Manufacturing Engineering.
- 815 years of experience in precision sheet metal manufacturing, preferably in medical devices or aerospace.
- Six Sigma Green Belt / ISO 13485 Internal Auditor certification preferred.
- Experience in new product industrialization and process validation is essential.

Position Type

Full-time | On-site | Leadership Track – Individual Contributor with cross-functional influence.

📌 Assistant Manager / Deputy Manager - Process Owner - Sheet Metal (Kanchipuram)
🏢 Motherson Health and System
📍 Kanchipuram