Key Responsibilities • Execute day-to-day manufacturing of urology medical devices. • Prepare and maintain Batch Manufacturing Records (BMR) and production documentation. • Ensure compliance with ISO 13485, GMP, and company Quality Management System. • Coordinate with QA, QC, R&D, Engineering, and Supply Chain for smooth production. • Monitor production output, yield, rejection, and machine utilization. • Support process validation (IQ/OQ/PQ) and manufacturing transfers from R&D. • Implement process improvements to enhance productivity and reduce waste. • Ensure line clearance, traceability, and product identification throughout manufacturing. • Participate in deviation, CAPA, NCR, and root cause investigations. • Train operators on manufacturing procedures and good documentation practices. • Maintain 5S, safety, and cleanroom discipline in production areas. Requirements Educational Qualification • Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline. • Preferred: 1–5 years of experience in medical device manufacturing. Technical Skills Required • Medical device manufacturing processes • ISO 13485 & GMP • Good Documentation Practices (GDP) • Process Validation (IQ/OQ/PQ) • Lean Manufacturing & 5S • Root Cause Analysis (5 Why, Fishbone) • SAP/ERP production transactions • Microsoft Excel & production reporting Competencies • Strong analytical and problem-solving ability • Cross-functional collaboration • Attention to detail • Communication skills • Ownership and accountability • Continuous improvement mindset Benefits Hiring this role will provide the following benefits: • Increase manufacturing capacity for the expanding Urology Solutions portfolio. • Reduce production bottlenecks and improve on-time order fulfillment. • Strengthen compliance with ISO 13485 and regulatory manufacturing requirements. • Improve process efficiency, yield, and overall equipment utilization. • Support successful transfer of new products from R&D into commercial manufacturing. • Enhance documentation accuracy and reduce deviations, NCRs, and rework. • Enable scalable production for CE, RoW, and future global market expansion.