Sr Mgr /Assistant General Manager Operations/ Medical devices/Rajkot

Hiring for Plant Manager operations (Sr Manager/AGM ) Medical devices mfg.

Plant Manager Orthopedic Implant Manufacturing

Location: Rajkot, Gujarat

Reporting To:

Associate Vice President Operations and Supply Chain

Job Overview:

We are seeking a visionary and technically proficient Plant Manager to lead operations at our orthopedic implant manufacturing facility in Rajkot. This strategic role demands strong hands-on leadership in machine operations, process automation, and smart manufacturing. You will be instrumental in establishing a future-ready plant that leverages Industry 4.0 technologies, IoT-integrated machinery, and digital systems to deliver scalable, compliant, and cost-effective implant production.

The ideal candidate will combine deep experience in medical device manufacturing with a passion for innovation and operational excellence.

Key Responsibilities:

1. Plant Setup & Industry 4.0 Strategy

• Lead greenfield project execution including plant layout, machine selection, utility infrastructure, cleanroom setup, and sterilization areas.
• Drive implementation of IoT-enabled machines, automated data collection, and real-time performance monitoring systems.
• Collaborate with automation and IT teams to integrate MES, SCADA, or Industry 4.0 platforms for enhanced shop floor intelligence.
• Define and implement the plants digital operating model aligned with smart manufacturing principles.

2. Advanced Manufacturing Operations

• Lead daily operations with a strong focus on machine utilization, predictive maintenance, and OEE improvement.
• Supervise high-precision equipment such as multi-axis CNCs, robotic polishing arms, laser marking, 3D measurement systems, etc.
• Implement Lean, Six Sigma, and TPM to eliminate inefficiencies and ensure process stability.
• Champion initiatives like digital batch records, QR-coded material tracking, and automated process control systems.

3. Regulatory & Quality Compliance

• Ensure all production processes meet ISO 13485, FDA 21 CFR Part 820, and EU MDR standards.
• Support equipment qualification (IQ/OQ/PQ) and maintain electronic calibration logs.
• Maintain full traceability and audit readiness through digital documentation systems.

4. Smart Supply Chain & Inventory Control

• Work with planning teams to optimize inventory through real-time demand sensing, digital Kanban, and MRP tools.
• Coordinate raw material flow (e.g., Titanium, Stainless Steel, Co-Cr) with automated stock tracking and alert systems.
• Enable digital dashboards for capacity and production planning aligned with machine-level data.

5. Leadership & Team Enablement

• Recruit and mentor cross-functional teams in production, engineering, EHS, and maintenance.
• Foster a high-performance, safety-first culture backed by continuous training on new tech and automation systems.
• Build strong collaboration with R&D, Regulatory, and Commercial teams for seamless design-to-manufacturing handoff.

6. Engineering & Equipment Expertise

• Evaluate and lead commissioning of next-gen production technologies such as:
• High-speed CNCs with remote diagnostics
• Automated deburring and polishing systems
• IoT-based environmental monitoring for cleanrooms
• Drive structured preventive maintenance and machine uptime using CMMS or equivalent platforms.
• Lead continuous product and process improvement through robust CAPA systems and technical root cause analysis.

7. Cost Control & Smart Budgeting

• Develop plant budgets and drive cost optimization through energy-efficient machines and productivity analytics.
• Monitor cost per unit using real-time dashboards and drive data-backed cost-reduction initiatives.

8. EHS & Digital Risk Management

• Enforce EHS standards integrated with real-time safety alerts, compliance checklists, and digital incident logs.
• Implement system-driven risk assessments and audits to proactively identify and mitigate operational risks.

Key Skills & Competencies:

• Strong command over CNC technology, automated polishing, laser systems, and packaging automation.
• Familiarity with implant-grade material specs (ASTM F136, F138).
• Hands-on experience with Industry 4.0, IoT integration, and data-driven decision making.
• ERP/MRP proficiency (SAP, Oracle, JD Edwards); MES/SCADA knowledge is a strong plus.
• Ability to lead unionized workforce and manage multidisciplinary teams with agility and discipline.

Educational Qualifications:

• B.E. / B.Tech / M.Tech in Mechanical, Production, Biomedical, or Industrial Engineering.
• Certifications in Lean, Six Sigma (Green/Black Belt), PMP preferred.
• Additional training in Industry 4.0 technologies, automation, or medical device regulatory compliance is highly desirable.

Experience Required:

• 15-20 years of experience in high-precision manufacturing; at least 5-6 years in a plant leadership role.
• Deep familiarity with orthopedic implants or other regulated medical device manufacturing.
• Experience in startup environments or greenfield project execution will be a strong advantage.

Work Environment:

• Entrepreneurial, fast-paced culture focused on innovation and agility.
• Opportunity to lead the transition from traditional manufacturing to a digitally-enabled smart factory.
• Significant ownership and visibility in building a future-ready implant production facility.

to apply share resumes with Puja.k@maxisclinical.com

Thanks

Puja Khemchandani