Head - Operation - Medical Device Manufacturing

Position: Head Operations Operations

Industry: Medical Device Manufacturing

Reporting To: CEO / MD.

Location: Manufacturing Facility -at Sanand , near Ahmedabad.

Role Overview

The Head of Operations will lead and drive the end-to-end manufacturing and operational strategy of the organization. The role is responsible for production, maintenance, safety, QA/QC, supply chain management, production planning, inventory control, and statutory compliance to ensure efficient, compliant, and scalable operations.

The incumbent will work closely with the Managing Director and senior leadership team to deliver operational excellence, regulatory compliance, cost optimization, and sustainable business growth in a regulated medical device manufacturing environment.

Key Leadership Responsibilities:

1. Operational Strategy & Plant Leadership

- Provide strategic direction for manufacturing operations aligned with the companys growth objectives.

- Lead plant operations including production, engineering, maintenance, quality, and supply chain functions.

- Develop and implement operational excellence frameworks to enhance productivity and reduce operational risks.

- Drive capacity planning, plant expansion, and automation initiatives.

2. Production & Manufacturing Excellence

- Ensure achievement of production targets, efficiency levels, and quality benchmarks.

- Improve Overall Equipment Effectiveness (OEE), throughput, and production yield.

- Implement Lean Manufacturing, Six Sigma, and continuous improvement practices.

- Optimize manufacturing processes to reduce waste and cost per unit.

3. Production Planning & Inventory Optimization

- Lead Sales & Operations Planning (S&OP) to align demand forecasts with production capacity.

- Ensure effective production planning and scheduling to meet customer delivery timelines.

- Optimize inventory levels for raw materials, WIP, and finished goods.

- Improve inventory turnover and working capital efficiency.

4. Supply Chain & Vendor Management

- Develop a robust and cost-efficient supply chain ecosystem.

- Strengthen supplier qualification, vendor development, and procurement strategies.

- Mitigate supply risks through strategic sourcing and supplier diversification.

- Drive logistics efficiency and on-time delivery performance.

5. Quality Assurance & Regulatory Compliance

- Ensure full compliance with medical device quality standards and regulatory requirements, including
Lead quality management systems, validation processes, and regulatory audits.

- Ensure consistent product quality and traceability across the manufacturing process.

6. Maintenance & Engineering Management

- Oversee preventive and predictive maintenance programs.

- Ensure high equipment reliability and minimal downtime.

- Lead installation, commissioning, and qualification of new manufacturing equipment.

- Drive automation and process modernization initiatives.

7. Safety, Health & Environment (SHE)

- Promote a zero-incident safety culture across plant operations.

- Ensure compliance with industrial safety, environmental regulations, and workplace standards.

- Conduct regular safety audits, training programs, and risk mitigation initiatives.

8. Statutory & Legal Compliance

- Ensure compliance with all applicable statutory regulations, including:

- Factory regulations

- Labour laws

- Environmental regulations

- Medical device regulatory authorities

- Maintain audit readiness and documentation for regulatory inspections.

9. Leadership & Organizational Development

- Build and lead high-performing cross-functional teams across production, quality, maintenance, and supply chain.

- Develop succession plans and leadership capability within operations teams.

- Foster a culture of accountability, operational discipline, and continuous improvement.

Key Performance Indicators (KPIs)

- Production efficiency and capacity utilization

- On-time order fulfillment

- Product rejection / defect rate

- Manufacturing cost per unit

- Inventory turnover ratio

- Machine downtime and maintenance performance

- Compliance and audit outcomes

- Workplace safety performance

Candidate Profile

Education

- Bachelors degree in Mechanical / Production / Industrial / Biomedical Engineering

- MBA in Operations / Supply Chain Management preferred

Experience

- 15+ years of manufacturing experience in precesion engineering / medical device company.

- Minimum 7-10 years in senior leadership roles managing plant operations

- Experience in medical devices, precession engineering , auto ancillary manufacturing preferred

Core Competencies

- Strategic Operations Leadership

- Manufacturing Excellence & Lean Transformation

- Supply Chain Optimization

- Regulatory & Quality Compliance

- Financial & Cost Control

- Cross-functional Leadership

- Data-driven Decision Making

Ideal Candidate Attributes:

- Strong plant leadership and operational execution capability

- Proven ability to scale manufacturing operations

- Experience managing regulated manufacturing environments

- Ability to partner with top management on strategic growth initiatives