Mena Haroon

• Responsible for the design, development, validation, verification, and implementation of new and revised manufacturing lines and integrated systems of manufacturing processes.
• Work closely with product realization teams to ensure product manufacturability and successful transfer to production.
• Spearhead process optimization projects that aim at increasing production capacity while lowering COGS using lean manufacturing methods such as SWCS, Heijunka, and Yamazumi charts.
• Set up new manufacturing equipment and production lines including the selection and training of process technicians.
• Author documentation in accordance with the BMT’s QMS and develop new manufacturing methods/best practices.
• Support and mentor Junior engineers on fundamental manufacturing principles and methodologies.

• Led operations efforts through a complete redesign of one of the company’s disposable devises using SLA additive manufacturing technology; successfully transferred design into European market and 510k FDA submission
• Oversee manufacturing processes of assembling disposable devices and capital equipment to ensure workflows are smooth and efficient
• Look for opportunities to automate and streamline processes for ramping up production
• Work closely with design teams through the design phases to ensure manufacturability, reliability and testability of products
• Asses design process capabilities such as tolerance analysis, design for six sigma, and FMEA
• Translate design documents and test specifications into manufacturing assembly and test instructions
• Create manufacturing forms that establish traceability of finished products
• Train and support operators accordingly
• Lead validation of production processes and equipment, manage validation resources, and perform PFMEA activities in accordance with ISO 13485 and FDA requirements
• Assist QARA team with audits by regulatory bodies
• Make appropriate use of quality systems including Change Requests/Orders (ECR/CO), Deviations, and Corrective and Preventive Action (CAPA) systems
• Investigate and resolve product Non-Conformance (NC) and Complaints
• Identify and qualify suppliers of custom parts
• Interact with contract manufacturers to resolve issues related to manufacturability
• Resolve obsolescence issues by specifying part alternatives or proposing design changes
• Perform cost analysis (parts and labor) and contribute to drive down product costs by suggesting changes to design, manufacturing process, and/or test methods
• Contributed to the deployment, customization, setup and validation of company’s new ERP system, Infor.

• Provided manufacturing services to multiple clients in the Medical Device industry such as Design Transfer to Production, Supply Chain activities, and production workspace setup.

• Managed Design Transfer to Production activities from initiation stage to release of DMR; Generated ECOs and BOMs; Created and maintained work instructions and travelers; Identified process risks by using PFMEA approach
• Resolved manufacturing issues through the use of Deviations, NCRs, and CAPAs; improved manufacturing efficiency by analyzing/planning workflow while applying lean manufacturing techniques such as KanBan and 5S
• Managed and supported Contract Manufactures to ensure subassemblies and custom parts are delivered on time, and according to engineering specification; Generated SCARs as required to ensure quality was always met
• Provided executive team with decision-making information by estimating production lead-time, labor and material costs, reviewing production schedules as well as estimating future requirements
• Implemented, supported, and maintained quality requirements and standards to adhere with FDA, ISO 13485, ISO 9001, Health Canada, CSA, and TUV.

• Managed and supported processes in the production line
• These included Incoming Wafer QC, Die-Bonding, Wire-Bonding, Packaging, etc
• Optimized and re-designed existing instruments; developed automated Macros which increased throughput and productivity by 75%; supported manufacturing line in achieving 98% product availability
• Fully developed a chip production database using object-oriented software (C#) that sped up processes’ tracking by 50% and allowed us to track and record the progress of parts in the production line from start to finish
• Followed the Quality Management System activities, such as authoring SOPs, training, PFMEA and risk assessment methods, DHF/DMR, as well as verification and validation activities
• Expert in setting-up, programming, and operating semiconductor electronics assembly equipment.