Vaughan, Ontario, Canada
• Results-oriented and highly motivated professional with over 10 years of experience in the medical device industry, expertise in ISO 13485 standards, supported by a Bachelor of Science in Electrical and Electronics Engineering • Over 3 years of direct management experience across various roles, including Manufacturing Engineering, Service, and Production teams • Facilitating smooth transitions from prototype to mass production, including coordinating with R&D, QA&RA, System V&V, and supply chain teams to address and resolve any production challenges. • Proven ability to maintain effective communication with customers to ensure timely preventive maintenance, rework, and problem resolution, while driving continuous serviceability improvements • Detailed-oriented, highly motivated, and dedicated team player with leadership skills with the ability to learn fast and adapt to new environments. •Strong interpersonal and analytical skills proven by solving manufacturing and process issues
*Manage system redesign projects that improved product reliability, performance, manufacturability, and serviceability. *Lead and manage a team of manufacturing and service engineers and technicians, providing guidance, training, and support to ensure high levels of performance and productivity. *Develop and implement manufacturing processes and procedures to optimize efficiency, ensure product quality, and comply with regulatory requirements such as FDA guidelines and ISO standards. *Drive continuous improvement initiatives and lean manufacturing principles to enhance productivity, reduce waste, and improve overall operational performance. *Manage and oversee the implementation of new equipment, and technologies, to enhance manufacturing capabilities and efficiency. *Implement and maintain quality control measures throughout the manufacturing process, including inspection procedures, testing protocols, and documentation practices to ensure compliance with quality standards and regulations. *Monitor and analyze key performance metrics, such as production output, quality metrics, service response times, and customer satisfaction scores, to identify areas for improvement and implement corrective actions as needed. *Collaborate with cross-functional teams, including R&D, engineering, and QA&RA, to support product development, resolve technical issues, and introduce new products (NPI) to market. *Assist VP of Manufacturing & Service Operations with overseeing manufacturing operations. *Manage the service and support functions, including field service technicians, customer support representatives, and service contracts, to provide timely and effective support to customers and ensure high levels of customer satisfaction. *Develop and maintain relationships with key customers, distributors, and partners to understand their needs, address concerns, and identify opportunities for business growth and improvement.
Managed day-to-day production operations, ensuring strict adherence to production schedules and quality standards. Led a team of 8 production staff, developing comprehensive training plans and providing ongoing coaching to enhance team performance. Developed and optimized production schedules to consistently meet deadlines and align with demand forecasts. Monitored production metrics and KPIs, spearheading continuous improvement initiatives to boost efficiency and reduce operational costs. Provided strategic manufacturing decision-making by calculating production, labor, and material costs; analyzing production schedules; and forecasting future manufacturing demands. Enhanced manufacturing efficiency through meticulous workflow analysis, space optimization, and equipment layout planning. Documented and thoroughly investigated nonconformance issues and Developed and refined manufacturing process maps (PMAPs) and master validation plans (VMPs) to improve process efficiency and consistency. Prepared detailed work instructions, assembly routing forms, and Device History Records (DHRs), while offering technical support to assembly technicians when needed. Assured product and process quality by designing and implementing testing methods, evaluating finished products, and confirming process stability and efficiency. Implemented LEAN/5S methodologies, utilizing process improvement tools to eliminate waste, optimize processes, and reduce costs. Ensured equipment operational readiness by coordinating maintenance and repair services, adhering to manufacturer guidelines, and scheduling special services when necessary. Developed and maintained process-related risk analyzes (PFMEA) by incorporating inputs from nonconformances, CAPAs, and design changes. Led new equipment and process qualifications to ensure seamless integration into production. Prepared for and participated in quality audits related to manufacturing and operations, ensuring compliance with industry standards.
·Develop robust, capable, cost-effective & safe manufacturing processes, equipment, materials, and products · Driving LEAN methodologies, and process improvement tools in the elimination of "waste" process steps and development of efficient, cost-effective equipment and processes. · Improving manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout. · Assuring product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes. · Keeping equipment operational by coordinating maintenance and repair services; following manufacturer’s instructions and established procedures; requesting special service. · Develop work instructions, equipment maintenance procedures, specifications, PFMEAs, PMAPs, and other quality documents. · Working to identify the manufacturing failure modes and developing tests capable of capturing these failure modes
• Developed and maintained layouts, work instructions and forms • led improvement projects and managed machinery/equipment maintenance inventory . • Provided technical support to production lines and set up automatic machineries • Led investigation and create non conformance and deviation reports • Planed and perform monthly/weekly preventive maintenance and repairs to prevent any unplanned downtime due to machineries and equipment breakdown.
•Led serviceability improvement, process optimization , and cost reduction projects (over $100k per year) •Participated at prototype installations and upgrades along with feedback for R&D. •Implemented process validation method, led process validation team included creating of PMAP, VMP, VMR, pFMEA, process validation protocols & reports. •Worked with R&D for investigations and provided R&D advice in order to resolve design issues. •Drived the realization of all Customer Service Deliverables towards the programs assigned •Reviewed and provided feedback on service requirement specifications (SRS), and assisted in creating service process specifications for NPI projects. •Coordinated with the Engineering and Operations on spare parts and tools readiness. •Represented customers and service as a core team member for program and technical design review meetings. •Coordinated and collaborated with technical writers in the creation of service manuals and introduction of these materials for field service engineers. •Experience in troubleshooting, system and application installations, maintenance, modifications and repair on complex multidisciplinary systems at customer site. •Maintained communications with customers, collected customer feedback to ensure resolution and proper follow-up, produced timely and detailed service reports for continues improvements. •Supervised CT/AMI System installation and upgrades at customer sites for process improvements.
•Managed engineering changes (ECR/ECO, CCB chairman) and engineering projects on production floor, including matrix management for different departments. • Coordinated design transfer from R&D to production, including establishment and management of product/machine BOMs. •Implemented new equipment in production line including (IQ, OQ, and PQ). •Prepared engineering specifications (URS, TM, FDS), developed new processes for production and supply chan. •Led V&V activities, Optimized production processes and provided training to employees on production line. •Created mechanical drawings using SOLIDWORKS and created electronic scheme using AutoCAD. •Collaborated with suppliers and sub-contractors to resolve manufacturing problems.
•Managed engineering changes (ECR/ECO, CCB chairman) including matrix management for different departments. •Managed prototype manufacturing along with feedback for R&D. •Led production process validation (included writing protocols and reports) in Israel and Europe. •Represented manufacturing as a core team member for program and technical design review meetings. •Reviewed and approved formal documents for PRS, SRS and R&D project specifications and followed up on engineering manufacturing deliverables. •Established and supported production lines in Israel and Europe. •Led investigations of production lines to identify root causes of the faults using 5Y and Fishbone methods. •Performed equipment qualification IQ/OQ/PQ. •Developed and improved work instructions for production lines, in addition to training production employees. •Collaborated with suppliers and sub-contractors to resolve manufacturing problems