About this role
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.