San Jose, California, United States
High performance Director with 25 years’ progressive leadership in project management, process improvement, customer relationship management, operations, R&D, and business strategy for a variety of companies. Outstanding communication skills with ability to motivate cross-functional and cross-cultural teams to complete projects on time and under budget. Creative problem solver. Solutions-oriented. Specialties: Program/Project Management, Manufacturing Management, New Product Introduction.
Oversee operations of all areas of manufacturing and service to deliver capital equipment and consumable products and direct activities so that approved products are manufactured on schedule and within quality standards and cost objectives. Manage all product development and sustaining engineering responsibilities. • Lead multiple projects through full design control process, from initiation to commercial release. Scope of projects vary from a full console device to smaller single use consumables. • Develop strategy and drive project to obtain NRTL certificate for spa device and commercialize. • Manage work flow of projects, including internal projects and external projects being completed by a contracted design house. Work flow includes requirement updates, verification and validation and release to production. • Lead insourcing project to bring handpiece manufacturing in-house from a contract manufacturer. Project led to over 50% decrease in COGs, along with better control of the supply chain, increasing supply and eliminating backlog. Project included development of relationships throughout the supply chain and bringing online over 30 suppliers for a device with over 50+ unique components. • Direct and monitor contract manufacturers, consultants, vendors and employees to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures. • Develop the manufacturing plan and establish procedures for maintaining high standards of manufacturing operations to ensure that products conform to established customer and company quality standards. • Support medical device CE mark application • Develop strategy and drive project to obtain NRTL certificate for spa device and commercialize. • Manage work flow of projects, including internal projects and external projects being completed by a contracted design house. Work flow includes requirement updates, verification and validation and release to production.
Responsible for Operations Departmental activities (MFG, Engineering, Quality, Procurement, Warehousing, Shipping, Operational Excellence, Finance, EH&S, Facilities, Service & Repair), collaborating with many other functions within the organization (e.g., Commercial, Product Development, etc.), to support the commercial production plan in three operations buildings for medical device products. Oversees and manages New Product Introduction, Manufacturing, Test, and Sustaining Engineering functions to establish and improve manufacturing processes, and product quality to meet company goals and objectives. Oversees and manages planning and managing all operations engineering activities and for improving organization performance by providing leadership and direction overseeing technology transfer of new products/processes to Operations and/or contractor manufacturers from R&D, improving yields, reducing product costs, and improving product quality and reliability • Set the strategic vision for the site, aligning all functions across Operations and Quality to shared objectives. • Manages the transfer of new products to manufacturing (or contract manufacturers), ensuring that the design for both manufacturability and testability have been incorporated. This also includes the IQ/OQ/PQ for all new processes & equipment. • Implements improved processes and management methods to generate higher ROI and workflow optimization.
Responsible for Operations Departmental activities (MFG, Engineering, Quality, Procurement, Warehousing, Shipping, Operational Excellence, Finance, EH&S, Facilities, Service & Repair), collaborating with many other functions within the organization (e.g., Commercial, Product Development, etc.), to support the commercial production plan in three operations buildings for medical device products. Oversees and manages New Product Introduction, Manufacturing, Test, and Sustaining Engineering functions to establish and improve manufacturing processes, and product quality to meet company goals and objectives. Oversees and manages planning and managing all operations engineering activities and for improving organization performance by providing leadership and direction overseeing technology transfer of new products/processes to Operations and/or contractor manufacturers from R&D, improving yields, reducing product costs, and improving product quality and reliability • Set the strategic vision for the site, aligning all functions across Operations and Quality to shared objectives. • Manages the transfer of new products to manufacturing (or contract manufacturers), ensuring that the design for both manufacturability and testability have been incorporated. This also includes the IQ/OQ/PQ for all new processes & equipment. • Implements improved processes and management methods to generate higher ROI and workflow optimization.
Responsible for the daily Manufacturing and Operations Engineering Departmental activities, collaborating with many other functions within the organization (e.g., QA, Development, etc.), and supporting the commercial production plan by providing assistance with technical issues which arise in Manufacturing. Oversees and manages New Product Introduction, Manufacturing, Test, and Sustaining Engineering functions to establish and improve manufacturing processes, and product quality to meet company goals and objectives. Oversees and manages planning and managing all operations engineering activities and for improving organization performance by providing leadership and direction overseeing technology transfer of new products/processes to Operations and/or contractor manufacturers from R&D, improving yields, reducing product costs, and improving product quality and reliability • Manages all manufacturing activities, including planning, scheduling, organizing, and staffing; assures that all manufacturing groups are coordinated, and that personnel in each group are properly qualified, directed, trained, and motivated to perform their duties effectively. • Responsible for all essential duties and responsibilities of the Operations Engineering Department by Managing the Director of Operations Engineering and providing leadership and technical advice to the members of the Operations Engineering team as needed • Manages the transfer of new products to manufacturing (or contract manufacturers), ensuring that the design for both manufacturability and testability have been incorporated. This also includes the IQ/OQ/PQ for all new processes & equipment. • Implements improved processes and management methods to generate higher ROI and workflow optimization. • In conjunction with the VP of Operations, sets strategy, budget, and goals for the operations department.
Responsible for the daily Manufacturing Department activities and for implementing initiatives and process improvements within Manufacturing, overseeing technology transfer of new products to the facility and/or contractor manufacturers from R&D (NPI), collaborating with many other functions within the organization (e.g., QA, Development, etc.), and supporting the commercial production plan by providing assistance with technical issues which arise in MFG. • Manages production scheduling and control systems to assure achievement of output schedules meeting Company delivery commitments; plans and develops manufacturing facilities and equipment for efficient production. • Manages all manufacturing activities, including planning, scheduling, organizing, and staffing; assures that all manufacturing groups are coordinated, and that personnel in each group are properly qualified, directed, trained, and motivated to perform their duties effectively. • Manages the transfer of new products to manufacturing (or contract manufacturers), ensuring that the design for both manufacturability and testability have been incorporated. This also includes the IQ/OQ/PQ for all new processes & equipment. • Works closely with the engineering and quality department in the roll out of new complex electronic products in accordance with required quality standards. • Works with accounting to establish standard costs and ensures that company quality objectives and factory cost objectives are met. • Maintains Demand Flow Technology (DFT) kanbans sufficient to assure the fulfillment of production schedules while also maintaining necessary inventory levels for FGI. • In conjunction with the VP of Operations, sets strategy, budget, and goals for the operations department. • Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
OnCore Manufacturing Services, NPI Velocity Group, San Jose, CA 2010 – Present Program Manager, Work with medical device customers during R&D and commercial marketed product phase; lead transition to manufacturing project from OnCore side during NPI phase, transitioning product into manufactured product at OnCore and in the future to a low cost center. Customer Relationship Management achievements: • Successfully transferred medical devices into facility, generating significant revenue for OnCore and a multiple of that number in revenue for OEM customer, increasing profitability for all parties. • Assist in developing box build manufacturing skill sets at OnCore who has been focused on Electronic Manufacturing; thrive on challenge to show internal team different systems that demonstrate OnCore innovation and expertise, increasing business. • Deliver accurate, prompt, professional and courteous service that meets or exceeds current and prospective customers’ reasonable expectations, growing stronger customer base. • Collaborate with Sales, Engineering, Manufacturing and Materials to establish internal support models for cost, quality and availability, facilitating accurate proposals and creating process improvement. • Recruited by OnCore based on customer referral for outstanding performance and service in prior job. Management achievements: • Assist in reorganizing and restructuring internal processes and operations, resulting in improved communication and more accurate tracking, generating ability to increase volume of concurrent projects. • Spearhead projects, identify technical specifications from customers/sales and coordinate resources, build schedules, prototyping, manufacturing and purchasing for timely delivery. • Direct priorities in product flow and analyze backlogs and sales forecasts in support of customer’s requirements, completing projects on time despite 30-50% additional customer requirements.