Head of Manufacturing - Ortho Devision

Head - Manufacturing, Ortho Division (Medical Devices)
Designation:  Sr. GM

Location:

Ahmedabad

Job Summary
A leading medical devices organisation is seeking an experienced manufacturing leader to oversee its orthopaedic devices production operations. This role covers multi-site manufacturing leadership, productivity enhancement, cost control, and strict adherence to regulatory standards including  ISO 13485, FDA, CE  and other applicable guidelines. The position requires driving process reliability, technology upgrades, and large-scale operational improvements.

Key Responsibilities
Develop and implement the manufacturing roadmap for the orthopaedic product line.
Lead planning, production, engineering, equipment maintenance, and operational excellence initiatives.
Drive capacity expansion, new technology adoption, automation, and scalability projects.
Ensure compliance with  ISO 13485, FDA, CE  and maintain audit readiness for all facilities.
Promote best practices across Ortho, Cardio, and other divisions to create unified manufacturing standards.
Work closely with Procurement, RA, Quality, Supply Chain and other functions to ensure operational continuity.
Support NPI/R&D teams with process validation, DOE, scale-up, and tech-transfer activities.
Monitor and improve KPIs such as OEE, yield, cost per unit, downtime, and throughput.
Lead Lean, Six Sigma and digital transformation programs to enhance efficiency.
Build a strong leadership bench across plant teams and ensure a culture of safety and compliance.
Manage budgets, cost optimisation, and capital expenditure planning.

Qualifications
18-25 years of experience in manufacturing, including senior leadership roles.
Strong exposure to medical devices or regulated sectors such as pharma, diagnostics, or biotech.
Experience managing multiple sites and driving major improvement programs.
Degree in Mechanical/Industrial/Production Engineering;
Master’s preferred.
Working knowledge of GMP, ISO 13485, risk management, and advanced manufacturing practices.
Certifications in Lean/Six Sigma/PMP are advantageous