M. Basha Bukhari, MBA, MS
Plastics Manager @ Rochester Precision Optics
About
• Skilled Project & Product Development Manager with emphasis on project management, product verification& validation, resource planning, risk mitigation, continuous improvement, Root Cause Analysis, and quality management system in the medical device manufacturing. • Experience leading program capital up to $4M • 17 years of professional experience: Completed over 120 mold validations from design to production. • Launch over 10 product lines from components, and assembly lines to finished products in both the medical device and electronic industry. • Experience in high-volume manufacturing of medical and electronic components and assembly. • Experience in Statistical analysis ANOVA, DOE, and SPC: Continuous improvement. • Working knowledge of quality standards ISO 13485, ISO 9001, and OSHA, Internal Audits. • Trained in Lean manufacturing, 5S, Kaizen, and Kanban. • Proficient in Minitab®, Microsoft Office, Agile, and SAP. • Working experience in IBM, EBM, extrusion, thermoforming, compression molding, hot stamping, and welding.
United States
Rochester
Medical Device
Technical Requirements, Technical Design, Purchase Orders, Quote, Customer Satisfaction, Communication, Project Teams, Product Development, ISO 9001, Project Management, Technical Leadership, Injection Molding, Molding, Troubleshooting, Plastics, Lean Manufacturing, Minitab, ISO 13485, Thermoplastics, Design for Manufacturing
Experience

R&D Program Manager
United States
• Ability to run global programs and interface effectively with team members and across different departments and countries. • Utilize product commercialization process (PCP) for project governance and deliverables. • Follow the stage gate process for the Program and ensure the phase gate reviews are met. • Ensure Project documents for each phase are met and maintain electronic Document History File in Agile. • Coordinate internal resources and vendors for the timely execution of projects. • Develop project scopes and objectives, involving all relevant stakeholders. • Ensure resource availability and allocation continuity as needed. • Develop a detailed project plan to track progress and all projects’ deliverables are met on time, within the scope, and budget. • Use appropriate verification techniques to manage changes in project scope, schedule, and costs. • Provide project updates consistently and escalate to management as needed. • Perform risk management to minimize project risks and maintain risk register with mitigate plan and timing update.

R&D Product Development Engineer
Rochester, New York Area
• Responsible for process validation and equipment installation across multiple sites within the North American region. • Communicates technical information in writing and verbally effectively and timely to the core team, stakeholders, and cross-functional department. • Manage own timeline and prioritizes against assigned tasks to meet or exceed deadlines by proactive interaction with suppliers, customers, program management, engineering, quality management, and procurement. • Strong management skills to detail project deliverables and milestones by determination of requirements, task assignments and tracking, communications to the program manager, and reporting the status to all levels of the organization as required. • Project Manager responsibility as needed based on company priorities for a resin replacement project, machine, and mold validation at other Thermo Fisher sites • Responsible for risk assessments and risk mitigation plans from the development phase through the validation phase of the project. • Review process specifications and development plans with cross-functional departments both internal and external, mold vendors, Auxiliary equipment vendors, contract manufacturers, and other service suppliers. • Responsible for completing Design for Manufacturing (DFM) reviews of new product designs, determining process feasibility and development options. • Responsible for selecting and specifying primary and secondary plastic processing equipment. • Develop project capital, product cost requirements, and COGM • Conduct operations user needs, develop OTM, PFMEA, Validation protocol, and reports. • Coordinate measurement and dimensional studies. Document results with detailed technical reports. • Execute FAT, IQ, OQ, and PQ qualifications activities for product launch.

Process Engineer Lead, Injection Molding
• Responsible for new project development activities; design concept generation and decision-making, design reviews, prototype building, and evaluation, DFMEA, tolerance analysis, design of experiments, process capability, design verification, milestone schedule management, and line trial activities. • Function as a liaison with project engineering, manufacturing, and the customer regarding the implementation of programs, both molding and secondary operations. • Coordinate, direct, and lead engineering efforts to ensure optimum engineering of projects as well as programs to meet customer and manufacturing requirements. • Redesign existing manufacturing processes to reduce product cost and manufacturability. • Create test plans for DOEs and process validations and process capability assessments and establish methods to control process output. • Lead engineers/technicians in IQ, OQ, and PQ when introducing new or changing existing manufacturing equipment. • Provide engineering support to the manufacturing floor and resolve issues impacting production fulfillment (e.g. troubleshooting existing manufacturing processes, fixtures, tooling, or equipment and resolving NCRs/ CAPAs). • Generates and maintains documentation for all internal processes, inspection criteria, Bill of Materials, and other manufacturing and quality records.

Injection Molding Process Engineer
Manchester, Connecticut
• Process validation using RJG decoupled molding and scientific injection molding. • Extensive process development experience from single cavity to 96 cavity mold, cold runner, hot runner valve gates, sequential valve gate, two-shot molding, insert molding, Spindle mold, and unscrewing mold. • Experience in thin wall molding and micro molding. • Extensive experience in engineering-grade, high-temp resins, and commodity resin, TPE. • Experience with Fanuc Robot, Arburg, Engel, Sumitomo machines, Yusin and Wittmann robots, EOAT, and Vision system. • Documentation, customer and vendor interaction, supply chain, and project tracking. • Train technicians, operators, and quality personnel on processing, troubleshooting, automation, inspections.

Molding Engineer
Establishes the molding process parameters for all production jobs; performs all new mold samples and tooling de-bugs, assuring ready for production. Provides technical support to the production floor and implements training process for operators. Provides technical support to improve and monitor production yields, reduce cycle time, and or correct quality flaws.
M. Basha Bukhari, MBA, MS's Contact Information
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