Job Purpose

To establish, validate, and continuously improve end-to-end manufacturing processes for orthopedic implants at Alkem Medtech. The role covers precision machining, surface finishing, externally managed coating processes, cleaning, packaging, and regulatory-compliant documentation, ensuring superior quality, operational efficiency, cost optimization, and full regulatory adherence.

Key Responsibilities

1. End-to-End Process Validation Ownership

- Develop and optimize machining processes for Knee and Hip implants (Co-Cr, SS 316L, Titanium alloys).
- Define and standardize process parameters for CNC, VMC, and 5-axis machining.
- Establish and validate robust process flows for coating operations (Plasma Spray / HA Coating /TiNBN coating).
- Validate turning and milling operations across machines to eliminate production bottlenecks.
- Evaluate and validate outsourced processes at supplier facilities to support strategic outsourcing decisions.
- Develop prototypes and machining programs for new machine installations and validate performance prior to production release.

2. Coating Process Management

- Oversee coating activities executed through approved international job workers.
- Develop and define coating specifications for NPI projects, including thickness, adhesion strength, porosity, and surface roughness.
- Ensure complete process validation of coated implants, including NPI validation.
- Support regulatory documentation related to coating processes and technical submissions.

3. Validation & Regulatory Compliance

- Plan and execute IQ, OQ, and PQ for machining and coating processes.
- Conduct MSA studies, process capability analysis (Cp/Cpk), and prepare validation reports.
- Ensure compliance with:




- Central Drugs Standard Control Organization (MDR 2017)
- ISO 13485

- Maintain Risk Management Files (PFMEA), control plans, and change control documentation.
- Support internal and external audits (CDSCO, ISO, customer, notified bodies).

4. Process Optimization & Cost Control

- Improve machining cycle times and reduce tooling costs.
- Minimize rejection rates in coating and surface finishing processes.
- Drive Lean manufacturing initiatives to enhance yield and reduce scrap.
- Optimize raw material utilization and manage WIP effectively.

5. Risk Management & Quality Systems

- Conduct PFMEA and update control plans for critical machining and coating processes.
- Perform structured root cause analysis for coating-related failures (adhesion issues, thickness variation, delamination).
- Implement effective CAPA and continuous improvement initiatives.

Required Qualifications

- B.E./B.Tech in Mechanical or Production Engineering
- 56 years of experience in orthopedic implant manufacturing
- Robust technical expertise in:
- CNC machining (Titanium & SS implants)
- Surface finishing and cleaning validation
- Coating technologies (Plasma Spray / HA Coating)
- GMP and Medical Device Regulations

Preferred Experience

- Exposure to export–reimport job work model for medical devices
- Experience in handling regulatory audits (CDSCO / ISO / USFDA)
- Working knowledge of ERP systems (SAP preferred)
- Lean / Six Sigma certification (Green Belt preferred)

Key Performance Indicators (KPIs)

- Cpk 1.33 for critical parameters
- Reduction in coating rejection (%)
- Zero major audit observations
- On-time validation and release of NPI projects
- Reduction in machining cost per implant

📌 Process Engineer - Orthopedic Implants (Gujarat)
🏢 Alkem MedTech Ortho
📍 Gujarat