Assistant Manager / Deputy Manager - Process Owner - Sheet Metal

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).
• Strong 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.