Process Engineer - Orthopedic Implants

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
• Strong 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