•Production Planning & Execution
•Prepare and execute daily, weekly and monthly production plans based on sales forecasts and customer requirements.
•Ensure timely production and delivery of finished medical devices.
•Plan manpower, machines, materials and production capacity.
•Monitor production output, productivity, rejection and rework.
•Identify bottlenecks and take corrective actions to improve throughput.
•Maintain appropriate production records and traceability.
•Manufacturing Operations
•Manage end-to-end assembly and manufacturing activities for electronic and medical devices.
•Establish and maintain standardised manufacturing processes, SOPs, work instructions and process controls.
•Ensure adherence to approved BOMs, drawings, specifications and manufacturing instructions.
•Drive line balancing, cycle-time reduction and productivity improvement.
•Implement 5S, visual management and lean manufacturing practices.
•Establish appropriate in-process inspection and testing checkpoints in coordination with Quality.
•Quality & QMS Compliance
•Ensure production activities comply with the company's ISO 13485 QMS and applicable medical-device regulatory requirements.
•Ensure adherence to approved processes, work instructions and quality standards.
•Work closely with the Quality team on non-conformities, CAPA, deviations, change controls and process improvements.
•Ensure proper batch/lot traceability and production documentation.
•Support internal, customer and regulatory audits.
•Ensure that only approved components, materials and processes are used in production.
•New Product Introduction & Scale-up
•Work closely with R&D/Product Engineering during transfer of products from development to production.
•Support Design Transfer / Manufacturing Transfer activities.
•Develop assembly processes, tooling, fixtures, test procedures and production documentation.
•Identify Design for Manufacturing (DFM) and Design for Assembly (DFA) improvements.
•Participate in prototype builds, pilot production and production validation.
•Establish scalable processes for increasing production volumes.
•Vendor & Supply Chain Coordination
•Coordinate with Procurement and vendors to ensure timely availability of components and materials.
•Work with vendors to improve component quality and consistency.
•Support qualification of new vendors and alternate components.
•Monitor material shortages that could affect production schedules.
•Coordinate with stores/inventory teams for material issuance and reconciliation.
•Team Management
•Lead and manage production operators, technicians and other manufacturing personnel.
•Define manpower requirements and support recruitment/training.
•Train employees on production processes, SOPs, work instructions and quality requirements.
•Monitor individual and team productivity.
•Build a culture of ownership, discipline, quality and continuous improvement.
•Cost & Productivity Improvement
•Identify opportunities for reduction in manufacturing cost, labour cost, material wastage and rework.
•Improve yield and first-pass acceptance.
•Drive initiatives for BOM optimisation and process simplification.
•Track key manufacturing KPIs and take corrective actions.
•Equipment & Manufacturing Infrastructure
•Ensure proper operation, maintenance and calibration of production equipment and tools.
•Identify requirements for new machinery, fixtures and testing equipment as production volumes increase.
•Coordinate preventive maintenance and minimise production downtime.
•Support development and commissioning of new manufacturing infrastructure.
Key Performance Indicators
The candidate will be evaluated on:
•Production plan adherence
•On-time delivery
•Production yield / First Pass Yield
•Rejection and rework rate
•Manufacturing cycle time
•Labour productivity
•Production cost per unit
•Material wastage
•Equipment utilisation
•Inventory / WIP management
•CAPA and deviation closure
•Audit compliance
•Reduction in customer complaints attributable to manufacturing
Candidate Profile
Education
•Bachelor's degree / Diploma in Mechanical, Electronics, Electrical, Industrial Engineering, Production Engineering or related discipline .
•Experience in medical devices, electronics, diagnostics, healthcare equipment or other regulated manufacturing industries preferred.
Experience
•5–10 years of experience in manufacturing/production , preferably in: - Medical devices
•Diagnostic equipment
•Electronic products
•Precision instruments
•Healthcare equipment
•Other ISO 13485 / regulated manufacturing environments
Technical Skills
The candidate should have practical understanding of:
•Production planning and control
•Electronics/electromechanical assembly
•BOM, drawings and engineering change management
•Manufacturing SOPs and work instructions
•Process validation
•Quality inspection and testing
•Root Cause Analysis and CAPA
•ISO 13485 / QMS
•Lean manufacturing / 5S
•Production KPIs and MIS
•Vendor and manufacturing process management
Knowledge of SMT manufacturing, PCB assembly, soldering, testing, calibration, mechanical assembly and electronic device manufacturing will be an advantage.
