Mayra Moore, Mba, Pmp Email & Phone Number

Santa Ana, California, United States

Santa Ana, California

• Managed and delivered on time multiple high profile new product development projects in the Structural Hearth business within $MM budgets. The new products met requirements from regulatory bodies and were clinically and commercially approved in the US, Japan, Canada, and EU. • Planned scenarios to accelerate a clinical trial start based on scope changes and schedule fast track. Submitted documentation to FDA to start clinical trials 6 months prior the initial planned date. This contributed to maintain customer engagement and commercialization ahead of competitors. Planned resources to support project acceleration.• Managed product supply and demand for clinical trials ensuring product availability and trial continuity. Drove prioritization of the build plan considering demand and challenges with component quality, vendor changes, and manufacturing capacity. • Implemented project management tools and led project management areas in programs (project planning, project contracting, schedule management, scope management, cost management, risk management, crisis management, stakeholder management, and communication management).• Defined project objectives and aligned with the business goals. • Managed and maintained variable expense and personnel forecast in addition to communicating resource needs to keep projects on track.• Worked cooperatively with the cross-functional Core Teams to generate, execute, and meet project contracts. Led the teams to define scope, assumptions, resources, timelines, product performance and metrics. Driven towards project results measured by delivering contracted scope on time, within budget and internal customer satisfaction.• Estimated timelines and resource needs for new technologies development to estimate NPVs and to evaluate business opportunities for Business Strategic Planning.• Influenced project strategies, cross functional project teams and stakeholders to ensure project milestones were achieved.

Santa Ana, California, Estados Unidos

• Responsible for the creation, maintenance, tracking and communication of project schedules. Successful coordination of work executed by over 100 people across 7 different sites and 3 countries, accomplishing various medical device commercial launches.• Influenced project strategies, cross functional project teams and stakeholders to ensure project milestones were achieved.• Personally coached and mentored project teams and PMO peers on Project Management, Product Development Process, and Design Controls.• Planned, coordinated, and presented in Design and Business Reviews, tracked deliverables to be completed on time and to meet the Design Control and Business requirements. • Generated Design Development Plans to reflect the Product Development strategy and meet Design Controls requirements.• Managed priorities and led crisis teams chartered with getting projects back on track. Applied complex critical thinking skills to resolve technical, budget, and schedule challenges.• Effectively communicated, and tracked project progress while delivering reports to teams and senior leadership.• Implemented project management tools and led project management areas in programs (project planning, project contracting, schedule management, scope management, cost management, risk management, crisis management, stakeholder management, and communication management).

Irvine, California, Estados Unidos

• Represented Operations simultaneously in five New Product Development Projects as Core Team Operations Representative. Led activities for the manufacturability of the product to make the transition of the product to the full-scale production.• Established production control methods to monitor process outputs and conducted risk assessments on the process to meet requirements. Directly responsible for the development and improvement of manufacturing processes in the Design Verification Phase to optimize product performance and results. • Led internal and external discussions & negotiations to define launch plans, launch strategy, capacity improvement projects, Voice of Operations, cost models, equipment analysis, and product forecast.• Generated product cost models, product cost estimation and analysis considering material, direct labor, burden, scrap and subcontractor cost. • Generated capacity models and capacity improvement plans.• Communicated with the internal and external cross functional areas (Global Supply Chain, Sales, Regulatory, Marketing and Finance) to coordinate activities for successful launches.• Assisted in identifying process delays and inefficiencies, while generating a plan to duplicate daily capacity in 5 months.• Led a cross functional team to repackage product affected by a product hold. • Supported supplier qualification activities to outsource stents and increase capacity. Generated analysis for stents demand.• Successfully developed & implemented a business case for a supplier project to replace markers on a neurovascular stent to save $MM annually.

Tijuana, Mexico

• Led the manufacturing transfer for four new Product Development projects (surgical and transcatheter aortic valves and endovascular stent grafts) in the Structural Heart and Aortic business ensuring manufacturability of the new product in addition to effectively transitioning the product to full-scale production.• Responsible for developing a plan for new products manufacturing start defining resources needed as capital request, equipment, tools and fixtures, direct and indirect labor resources, space requirements and line layouts.• Ensured overall project deliverables within a larger scoped project by meeting all task commitments. • Personally accountable for timeline efficiency and completion, as well as project performance and expenditure of projects.• Identified project risks, issues, and developed mitigation plans. Worked with the team to define technical solutions to problems during project execution.• Sustained, improved, and optimized manufacturing processes for Cardiovascular Products, Neurosurgery Products, Surgical and Transcatheter Heart Valves.• Established cost for new products considering material required, equipment investment, manufacturing expenses and direct labor. Defined strategies to achieve yields and financial goals.• Led negotiations between the R&D and Operations teams to make decisions related to process development and manufacturing.• Ensured that reports and activities executed by the team members were in compliance with the Quality System, project and Business requirements. • Led and managed technical personnel and engineers involved in the development and improvement of manufacturing processes for new products.

Tijuana, B.C Mexico

• Leader and coordinator for Patient Safety and Quality Standards certifications by the Mexican ‘Consejo de Salubridad General’ (Mexican General Health Council) and accreditation by the Joint Commission International for 4 hospitals in Tijuana, Mexico.

Tijuana, B.C Mexico

•Developed Medical Equipment Inventories and Controls•Developed Medical Equipment Preventive and Corrective Maintenance Programs•Developed Medical Technology Evaluation and Replacement Programs

Master Of Business Administration - Mba, Business Administration And Management, General

Bachelor Of Engineering (Be), Biomedical Engineering