Charlene Gonzalez

Experience

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  Hewlett-Packard

  Feb 1996 - Feb 2004

  • Lead planning, execution, and data analysis for R&D reliability test group for inkjet printing systems. • Lead global reliability project team for new product development, which included coordination of test requirements, global meetings, project updates, and project scheduling, for Singapore, Puerto Rico, Ireland, Barcelona, and San Diego facilities.• Worked with marketing and R&D in establishing product requirements and translating these into design requirements, using techniques such as Quality Function Deployment. Show less • Worked with suppliers, R&D, and manufacturing engineers in the design of new tools and new processes that would meet design requirements and support a robust manufacturing process. Responsibilities included tool reviews, first articles inspection, process capability analysis, and dock-to-stock certifications.• Participated in supplier selection and audits for sheet metal, elastomers, and injection molding suppliers in USA and Mexico, focusing on technical and quality aspects of their performance. Show less

  • R&D Reliability Engineer

    Mar 2000 - Feb 2004

  • Supplier Quality/Materials Engineer

    Feb 1996 - Feb 2000
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  Medtronic Cardiac Rhythm Division

  Feb 2005 - Feb 2010

  Engineering Project Leader

  • Project management for co-development project with USA facility of internal cardiac defibrillator. Activities included schedule management, planning and execution of pre-production builds, and manufacturing budget. • Improved quality and reliability of the product prior to manufacturing implementation by identifying top technical risks, and developing process solutions using Lean Sigma techniques. Provided yield improvement of 13% & cost avoidance of $200,000. • Lead product implementation for PR and Switzerland facilities for new defibrillator. Activities included equipment and process validations for new sub-assembly line, development of manufacturing documentation, and employee training and certification.• Represented manufacturing in product development core team, participating in design forums, escalating manufacturing issues, and providing manufacturing solutions and project updates to upper management. Show less

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  Medtronic Diabetes Division

  Jan 2010 - Jan 2013

  Engineering Manager

  • Manage product transfer, validations, and implementation of glucose sensors from USA facility to Puerto Rico. These activities included clean room validation, equipment and process validations, coordination of cross functional support Quality, Operations, Finance, Supply Chain, Facilities, EHS, and Microbiology. • Lead start-up of manufacturing operations for glucose sensors at PR facility, increasing production output by 90% and production yields by 20% in the first six months of production.• Implemented Lean Six Sigma in production environment, including 5S and Visual Management system for daily monitoring of production metrics and business objectives. • Manage and coordinates the work of staff of 50 manufacturing direct and indirect labor personnel, engineering, and technicians.• Manage sustaining engineering activities, cost reduction projects, capacity projects, productivity improvement initiatives, and Lean Sigma projects.• Perform capital budget and financial budget for engineering and operations of glucose monitoring sensors business unit. Develop business metrics per strategic planning process.• Development of master validation plans. Review and approve all equipment and process validations for Sensors manufacturing. Provided coaching to technical staff on statistical analysis for process validations. Show less

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  Medtronic Juncos Site

  Jan 2013 - now

  Sr. Engineering Program Manager

  - Program manager for Engineering, Sourcing, and Compliance projects for multiple business units at the Juncos site: Implementation of new manufacturing line at China, Outsourcing project with Mexico, Compliance (CAPA) projects, process development and implementation of new manufacturing lines at Juncos, implementation of product and process changes for released products.- Develop and manage strategic plans, master project schedule, and project budget for these programs. Complex projects included up to four phases in four years, and project budget above ten million dollars.- Coordinate device level implementation activities with multiple functional groups in PR and USA (R&D, Regulatory, Reliability, Microbiology, Electrical Testing) working with global sites across Medtronic, including four USA facilities, Switzerland, Singapore, and China.- Develop and manage component sourcing ramp-up plan.- Lead technical and process development activities such as equipment development, design reviews, process characterizations and validations. Juncos subject matter expert on process validations.- Manage project communications including updates to Medtronic and supplier senior management.- Supported Regulatory Agency audit readiness, compliance (CAPA) projects related to process validation and monitoring, and quality initiatives related to New Product Implementation, Validations, and Engineering Changes.- Manage team of engineers, contractors, and interns, and extended team from other Juncos functional groups, USA and global facilities Show less