Muhammad Mahmudul Haque

• Led the EU MDR compliance programme for WheelAir, Reshell, Custom Seating, and ActivCair, developing complete technical documentation including Technical Files, Risk Management Files, GSPR, Clinical Evaluation Reports (CER), PMS, PMCF, IFUs, Declarations of Conformity, and regulatory submissions.
• Led New Product Introduction (NPI) projects from concept through design transfer, manufacturing readiness, regulatory compliance, EUDAMED registration, production documentation, and commercial launch.
• Supported the implementation and continuous improvement of the Quality Management System (QMS) to strengthen ISO 9001 compliance and operational excellence.
• Reduced repeat manufacturing rework by applying root cause analysis, visual management, corrective actions, and implementing a centralised Rework Master File.
• Optimised demo stock management and inventory control processes to improve product availability and minimise waste.
• Managed customer complaints, non-conformities, and field issues for WheelAir by conducting root cause investigations, implementing corrective and preventive actions (CAPA), coordinating product rework, and driving continuous product improvement.
• Delivered Standard Minute Value (SMV) and work measurement training, standardising labour efficiency measurement and production performance reporting.
• Collaborated with engineering, quality, production, suppliers, and regulatory stakeholders to ensure successful product development, compliance, and manufacturing readiness.

Success Story:

• Improved Facility Layout of the organization
• Successfully completed MDR compliance programmes covering four medical device product families, enabling regulatory readiness for EU market entry.
• Developed more than 40 MDR technical documents supporting Class I and Custom-made medical devices.

• Inspect in-process items to ensure compliance with established quality standards.
• Accurately document test results, defects, and corrective actions, and maintain records within the SAP system.
• Operate automated patient cassette set manufacturing machines and troubleshoot issues as needed to ensure smooth operations.
• Stay up-to-date with ISO 13485 and FDA requirements to ensure strict adherence to internal and industry quality standards.

• Conducted detailed training, assessments, and certifications for all employees to ensure full GDPR compliance.
• Designed and implemented a comprehensive framework to enhance and sustain GDPR compliance policies
• Work Based Learning Research Title: Improving GDPR Compliance at ERNACT: Assessment and Framework development.

• Led Lean Manufacturing and Industrial Engineering functions across multiple production facilities, driving operational excellence and continuous improvement initiatives.
• Control Man-machine Ratio (MMR) by providing automation and optimum use of resources.
• Established Lean culture through Value Stream Mapping (VSM), OEE, Kaizen, SMED and Visual Management.
• Managed capital expenditure, machine budgeting and workforce planning to support business growth.

Success Story:

Increased overall plant efficiency by 16% through Lean transformation initiatives.

• Led Reliability Excellence, Production Excellence, and Capital Excellence programmes across manufacturing operations.
• Prepared cost-benefit analyses to evaluate and prioritise continuous improvement and capital investment initiatives.
• Implemented Zero Defect quality strategies to improve product quality and reduce manufacturing defects.
• Planned, coordinated, and led cross-functional project initiatives, ensuring on-time and successful implementation.
• Conducted periodic project reviews, monitored progress, identified improvement opportunities, and developed corrective action plans.

Success History:

• Efficiency Improvement by 6% whereas Overall Manpower Optimization of 2.18%
• Hitting average pick target 9 days to 5 days in changeover.

• Estimated production costs and established standard piece rates for new product launches using Predetermined Motion Time System (PMTS), standardising the production costing process.
• Designed and optimised production layouts, equipment positioning, and workspace using AutoCAD, incorporating ergonomic principles to maximise efficiency and productivity.
• Collaborated with production and quality teams to resolve manufacturing issues, improve product quality, and reduce costs through Six Sigma methodologies.
• Led the implementation of the Kaizen Roadmap

Success History:

• Improving Bleaching and Printing, Inspection of pillow cage, Quilt Cover stitching efficiency by 4%, 11%, 5% and 3% respectively.
• Manpower rationalized by 15.34% and 18.18% in fabric Inspection and Pretreatment area respectively.

• Managed Industrial Engineering, Maintenance and Warehouse operations for a large manufacturing facility.
• Led factory layout design, production planning, preventive maintenance and inventory management.
• Developed SOPs, maintenance systems and warehouse processes to improve operational efficiency.

Success History:

• Successfully supported the establishment and operational launch of a new manufacturing facility.

• Conducted end-to-end Value Stream Mapping (VSM) to identify value-added and non-value-added activities across the entire supply chain, from suppliers to customers.
• Developed current-state and future-state value stream maps to improve process flow and eliminate waste.
• Designed facility layouts using AutoCAD, ensuring optimum workflow, space utilisation, and compliance requirements.
• Developed policies for recruitment, performance appraisal, and production incentive programmes.
• Developed and delivered training programmes for production and quality management teams.

Success History:

• Set up 23 Lingerie production lines and lift up efficiency from 23% to 46% within 4 months with the trained skilled manpower.