Sonia Y. Cortes Email & Phone Number

France

Developed and Implemented a regulatory activity metrics framework by leveraging global, regional, and local processes using multiple data sources and regulatory activities (Lifecycle Management and New Products).

Ville De Paris, Île-De-France, France

• Led the Impact Assessment & Execution Strategy for Global Regulatory Projects, such as the New EU MDR Implementation of over 100 internal changes.• Supported the supply chain process to ensure the optimal plan for each country is established early in the process and avoid backorders. Identify risks and issues, and escalate as necessary. • Managed large amounts of changing, complex, and/or ambiguous information from multiple sources and made timely and effective decisions for the execution of project objectives.

• Ensured the sales process completion, from case planning to execution and payment. • Led market size studies, procedures mapping, and market share analyses and supported the key account’s contacts mapping and targeting. Supported the accounts segmentation and targeting, and provided input for efficient sales territory development and effective sales strategies.• Connected with main accounts for franchise positioning and branding, met with KOLs for professional education plans development, the definition of KOLs symposium, and preceptorships participation. Identify customer pain points & user needs.• Performed three new product introductions, including training internal and external customers on the use of the new product.

• Managed the surgical operational team and provided strategic and operational planning to ensure technical service delivery in the operating room (OR), managed ~1M USD overall budgets allocated to surgery and operating room service. Ensured technical capacity to serve 100% of scheduled and non-scheduled surgeries while reducing headcount and lowering costs by 20% in less than 1 year.• Supported the development and execution of a new go-to-market model for the orthopedics and surgical technologies division in collaboration with the commercial, healthcare compliance, and finance teams• Provided continuous improvement mindset, led, and implemented 6 process improvement initiatives and 5 service level agreements for our strategic clients/accounts

• Managed three new product launches and two product change projects, from conception to deployment ensuring on-time delivery.• Supervised engineering team and ensured project milestones were appropriately executed and timelines were met• Developed and implemented an increase of production capacity plan for the main Sports Medicine suture supplier (timeline owner, resource allocation, direct reporting on project progress with management).• Developed and supported the execution of 10 Part Submission warrants with external suppliers.

• Developed inspection methods, Measurement System Analyses, and statistical sampling plans for testing and validations. Developed & performed product and process risk analyses (pFMEA, dFMEA, cFMEA).• Generated, reviewed, and approved technical documentation (Standard Operating Procedures, protocols, and reports for validations/component qualifications, design control documentation, risk analyses, part & process specifications, and quality reviews).• Supported external and internal audits of the quality system and performed supplier quality audits, ensuring compliance with EU/US legislation and policies.Trained suppliers in China on the Production Part Approval Process (PPAP)

Flagstaff, Arizona Area

GORE®TIGRIS® Vascular Stent•Developed design specifications and managed design control documents (design inputs/design outputs and design inputs-outputs matrix)•Participated in market research for new designs and design changes for launched products •Wrote multiple 30-day submissions to the FDA for manufacturing process improvement / design changes and participated in live regulatory submissions to obtain CE mark •Determined process capability and implemented continuous manufacturing improvement initiatives•Originated nonconformance reports, authored and executed associated written plans for product disposition and led Corrective Action Preventive Action (CAPA)•Supervised summer interns: provided training on products and quality systems and oversaw the intern’s projects to ensure timelines were met

Flagstaff, Arizona

Manufacturing support for the GORE® VIABAHN® Endoprosthesis Endoprosthesis for treating Peripheral Vascular Disease (PVD) in the superficial femoral and Iliac arteries•Performed Design of Experiments (DOE) and design control activities (design verifications, design validations and shelf life studies) •Applied LEAN/Operational Excellence (OPEX) principles including 5S, Value and Waste, Process Mapping•Led efforts that improved process yields in 2 manufacturing plants by 4% in 8 months to reduce waste and increase efficiencies which resulted in ~80K USD monthly savings

Madison, Wisconsin Area

Lung tissue characterization via Ultrasound analysis and evaluation

Performance / Operability: Jet Engine System evaluation and analysis using in-house simulation programs for both commercial and military engines

Project Title: Characterization of the Onset of Fibric Damage in Type I Collagen FasciclesStudy to improve the training capacity and efficiency of athletes through probing of the mechanical limits of the biomaterial collagen

Project: Vortex Motion and Unsteady Turbulent Jet PenetrationLed successful experiments studying turbulent jet tip penetrations in effort to optimize the engines and reduce emissionsSet up Schlieren system to visualize profiles of different gases with ranging diameter nozzles and pressure profiles and responsible for organizing data acquisition and storage through Matlab programming;

Functioned as a full-time engineer working on flexible and rigid packaging Research and Development Performed characterization of a new bio-polymer through laboratory testing and analysisParticipated in brainstorming sessions on Critical Enabling Technologies for Packaging, contributing with innovative ideasEffectively communicated with business department/teams and suppliers, as well as cross-functional teamsProjects focused on packaging design and development as well as equipment qualificationProvided support in the commercialization of a new product

Research project: Site Specific Nanowire GrowthGrew zinc oxide nanowires via the VLS mechanism using gold as a catalyst, performed lift off lithography and SEM imaging, and problem solving initiative

M.S, Biomedical Engineering

Activities and Societies: *Graduate Engineering Research Scholars (GERS) *BME Graduate Student Association2D Biomechanical Tissue.

B.S, Mechanical Engineering

Activities and Societies: Institute of Mechanical Engineers (IIM), ASME, SHPE