Role Summary

This role will lead the overall Process Engineering and Recent Product Development function for Alkem Medtechs Orthopedic Division.

The incumbent will drive development, industrialization, and commercialization of advanced implant technologies including Ceramic Knee Systems, Zirconium Knee Implants, Medial-Pivot Knee, and complete Surgical Instrument platforms, while ensuring scalable, compliant, and cost-effective manufacturing readiness.

This is a strategic leadership role responsible for building future product capability and strengthening technological differentiation in the orthopedic segment.

Strategic Responsibilities

1. Portfolio Expansion & Technology Leadership

- Lead development of next-generation orthopedic systems:
- Ceramic Knee Implants
- Zirconium-based Knee Systems
- Medial-Pivot Knee Systems
- Associated surgical instruments and trays

- Evaluate material feasibility (Ceramic, Oxinium/Zirconium, Co-Cr, Titanium).
- Establish long-term technology roadmap aligned with business growth targets.
- Drive Make vs. Buy decisions for advanced materials and special processes.

2. End-to-End NPD Ownership

- Lead multiple concurrent NPD programs from concept to commercial launch.
- Drive DFM, cost modelling, manufacturability validation, and pilot production.
- Ensure structured stage-gate execution and milestone adherence.
- Reduce time-to-market for strategic product launches.

3. Process Engineering Leadership

- Head overall process engineering including:
- CNC / 5-axis machining strategy
- Advanced machining for ceramics & zirconium
- Surface finishing & cleaning validation
- Coating process validation (Plasma Spray / HA) via international job work

- Establish robust validation framework (IQ/OQ/PQ, Cp/Cpk 1.33).




- Build scalable manufacturing systems for future volume growth.

4. Regulatory & Compliance Governance

- Ensure complete compliance with:
- Central Drugs Standard Control Organization (MDR 2017)
- ISO 13485

- Approve and oversee Risk Management Files (PFMEA), control plans, and validation reports.
- Lead technical readiness during CDSCO, ISO, and customer audits.

5. Supplier & Global Coordination

- Lead technical collaboration with international coating partners.
- Validate outsourced processes and supplier capabilities for advanced materials.
- Establish strategic vendor development for instruments and precision components.

6. Team Leadership & Capability Building

- Build and mentor a high-performance Process Engineering & NPD team.
- Define competency framework for machining, materials, and coating technologies.
- Introduce Lean and Six Sigma culture in development and ramp-up phase.

Financial & Operational Accountability

- Achieve target cost per implant for Ceramic & Zirconium knees.
- Improve process capability and reduce rejection rates.
- Optimize tooling and material utilization for high-value materials.
- Ensure on-time commercial launch of new platforms.

Required Profile

- B.E./B.Tech in Mechanical / Production Engineering (Masters preferred).
- 12–15 years of experience in orthopedic implant manufacturing.
- Proven experience in leading complete knee system or complex implant NPD.
- Strong expertise in:
- Advanced CNC machining
- Ceramic and special material machining (preferred)
- Implant coatings and surface technologies
- Regulatory compliance in medical devices

Key Performance Indicators (KPIs)

- Successful launch of Ceramic & Zirconium & Medial Pviot Knee Systems
- On-time NPD commercialization
- Target cost achievement for new implants
- Zero major audit non-conformities

📌 Head - Process Engineering & NPD (Orthopedic Implants) (Rajkot)
🏢 Alkem MedTech
📍 Rajkot