Maya Garcia Esparza

Responsible to manage the design transfer of new product launches, bringing new products from R&D to low-volume commercial manufacturing for client companies providing manufacturing and validation leadership and engineering expertise.

• Lead project management efforts for E2E supply chain implementation of new products.
• Lead the validation and operations teams and collaborate with customers during feasibility, qualification builds and through commercial production ensuring operations predictability.
• Collaborated with Technical Leaders and cross-functional teams in establishing development strategy and resolve technical issues.
• Communicate project status, schedule progress and key project metrics through standardized processes for program management.
• Organize and deliver project presentations and technical review to leadership and customers
• Build and support manufacturing engineering strategies to ensure design controls and commercial milestones.
• Leverage data and insights to inform conclusions and support decision-making.
• Provide process validation expertise for IQ, OQ, PQ, TMV, Software Validation, Process Characterization.
• Input on Statistical analysis for process validations
• Partner with research and development to ensure DFM during early stage of product development.
• Manage all NPI related communication of multiple projects through organization by bringing visibility on key issues with an adequate business solution to the customer.
• Find opportunities for design and process improvements and drive implementation to ensure business continuity.
• Influence design specifications and processes to achieve the best quality and optimized for cost, manufacturability, supply chain flexibility and operational efficiency.

Lead and deliver global new projects for cataract surgery guided cross-functional teams to ensure strategic alignment and execution of the project deliverables, on schedule, within budget, and to the required quality standards

• Developed and executed project plans and roadmaps for new projects.
• Collaborated with Technical Leaders and cross-functional teams in establishing development strategy and resolve technical issues.
• Facilitated cross-functional communication between R&D, Marketing, Operations, Quality Assurance and Clinical/ Regulatory organizations.
• Partnered with strategy and business development to identify new product opportunities, manage project portfolio and work assignments.
• Established communication with stakeholders to ensure project team and inform project activities.
• Resolved issues, conflicts and project bottlenecks, negotiating effectively with others.
• Leveraged data and insights to inform conclusions and support decision-making.
• Organized and delivered project presentations and technical review to leadership.
• Managed capital and expense budgets, prepared annual project budgets.
• Lead PMO process improvements

Lead line transfers from sending site to receiving site for Neurosurgical products. Coordinated E2E supply chain implementation providing cross-functional technical expertise on validation strategies for design transfer.

• Developed and executed project plans and roadmaps for line transfers and site decommissions
• Developed and qualified new suppliers.
• Lead internal and external plants for successful line transfers
• Developed and executed design and process validation protocols (IQ, OQ, PQ, TMV, PVE, CSV, DV)
• Developed manufacturing work instruction procedures and supporting documentation
• Provided leadership and direction to technical staff (Engineers and Technicians).
• Developed systems of organization and efficiency to increase production by 60%.
• Developed automation tools to improve efficiency, eliminate waste.
• Supervised processes to eliminate weak points or bottlenecks in business operations.
• Mapped process workflows to enhance understanding of procedures
• Assisted engineers in developing, building, and testing prototypes and process.
• Developed and enhanced personnel work instructions to clear up confusion and boost performance.

Lead Endovascular new product launches of moderate to significant complexity. Contributed critical expertise across new product lines coordinated multi-functional teams at different plants during launch and stabilization period.

• Developed and executed project plans and roadmaps for new product launches.
• Lead project management efforts for E2E supply chain implementation of new products.
• Lead, redacted and executed process validations protocols for new products launches (software Validation, IQ, GR&R, OQ/PQ, TMV, engineering studies and dry Runs)
• Lead supply chain readiness workshops with cross-functional areas (Manufacturing, Quality, R&D, Marketing, Customs, Planning, Demand Plan and Product Management).
• Drove continuous improvement culture in engineering to provide clear product design standards, improve manufacturability through enhanced documentation and reduce engineering cycle time.
• Tested completed projects for functionality and implemented changes to production methods to rectify issues in final products.
• Directed, guided and monitored support engineers and in-house operational personnel.
• Directed, mentored and monitored support engineers and technicians for improved deployment.
• Created designs at minimal costs using high-volume manufacturing processes and careful material selection.
• Developed packaging testing, Sealing DOE, Transit Test, Environmental Test, Drop Test, Pull Test.
• Developed and implemented prototype designs (Fixtures, Workstations, Poke-Yokes).
• Managed project capital.
• Implemented ETO sterilization process.

Support NPI engineering efforts for new product launces in the manufacturing site.

• Completed projects by effectively applying engineering, technical, and maintenance procedures.
• Performed work according to project schedules and high quality standards.
• Completed engineering projects and tasks within established timelines and budgets.
• Interpreted blueprints and technical drawings to analyze upcoming projects.
• Completed process and equipment validation protocols and reports (IQ, GR&R and Software validation)
• Support engineers with process validations (OQ and PQ)
• Performed statistical analysis (Normality, Cpk,ANOVA, T-Test)
• Conferred with engineers and designers to investigate and solve failure issues (troubleshooting).
• Coordinate with operations engineering testing (GR&R, dry runs and engineering studies)
• Created manufacturing layouts to improve manufacturing efficiency.

Automotive industry