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.
RequirementsEducational Qualification
Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or related discipline.
Preferred: 1–5 years of experience in medical device manufacturing.
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
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.
Skills Required
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Production Engineering, or a related discipline
- 1-5 years of experience in medical device manufacturing
- Knowledge of medical device manufacturing processes
- Knowledge of ISO 13485 and GMP
- Knowledge of Good Documentation Practices
- Experience with process validation, including IQ, OQ, and PQ
- Knowledge of Lean Manufacturing and 5S
- Root cause analysis experience using 5 Why and Fishbone methods
- Experience with SAP or ERP production transactions
- Microsoft Excel and production reporting skills
What We Do
Founded in 2006, Meril is an India-based global medical device company dedicated to innovating, designing, and manufacturing clinically relevant healthcare products. It develops vascular intervention, orthopaedic, diagnostics, endo-surgery, ENT, and robotic solutions, collaborating with physicians and global innovators to address unmet clinical needs. Through research, development, manufacturing, scientific communication, and distribution, Meril aims to alleviate human suffering and improve quality of life worldwide.
