Alkem MedTecgh Pvt Ltd

Job Purpose: To lead, optimize, and continuously improve manufacturing processes for orthopedic surgical instruments and implants. The role involves supporting new product introductions (NPI), commissioning advanced manufacturing technologies, and driving process excellence through digital transformation, Lean, and Six Sigma methodologies to ensure compliance with ISO 13485 and global medical device standards. Key Responsibilities: 1. Manufacturing Operations Lead daily production activities with a focus on machine utilization, predictive maintenance, and OEE improvement . Supervise precision manufacturing operations involving multi-axis CNCs, robotic polishing arms, laser marking, Ultrasonic cleaning and clean room operations. Drive structured preventive maintenance and maximize uptime using CMMS or equivalent platforms . Develop and maintain SOPs, process flow diagrams, and work instructions in line with QMS and EHS standards. Monitor key process metrics and initiate improvement projects for productivity, yield, and cost optimization. 2. New Product Introduction (NPI) Partner with R&D, Quality, and Supply Chain to ensure seamless industrialization of new products. Participate in DFM (Design for Manufacturability) reviews, prototype builds, and validation activities ( IQ/OQ/PQ ). Design and validate tooling, fixtures, and gauges to support new product launches. Conduct process capability studies and ensure manufacturing readiness before product release. 3. New Machine Setup & Technology Commissioning Evaluate and lead commissioning of next-generation production technologies , including: High-speed CNCs with remote diagnostics Automated deburring and polishing systems IoT-based environmental monitoring for cleanrooms Plan and execute machine installation, qualification, and handover (FAT, SAT, IQ, OQ). Coordinate with suppliers, utilities, and validation teams to ensure timely commissioning. Conduct training for operators and ensure safe, efficient operation of new lines. 4. Process Improvement & Digital Transformation Implement Lean, Six Sigma, and TPM principles to eliminate waste and enhance process capability. Champion digital manufacturing initiatives such as digital batch records, QR-coded material tracking, and automated process control systems . Lead continuous product and process improvement using structured CAPA systems and root cause analysis . Drive data-driven decision-making through performance dashboards and real-time process monitoring. 5. Documentation & Compliance Maintain process documentation, validation protocols, and change control records. Support internal, customer, and regulatory audits (ISO 13485, GMP). Ensure EHS compliance and adherence to medical device manufacturing standards. Key Skills & Competencies: Strong command over CNC technology, automated polishing, laser systems, and packaging automation . Familiarity with implant-grade material specifications (ASTM F136, F138) . Hands-on experience with Industry 4.0 technologies, IoT integration, and data analytics . Proficiency in ERP/MRP systems (SAP, Oracle, JD Edwards); working knowledge of MES/SCADA is a strong advantage. Ability to lead a unionized workforce and manage multidisciplinary teams with agility, discipline, and accountability. Strong communication, analytical, and problem-solving skills with a continuous improvement mindset.