Responsible of the New Product Introduction portion for 10+ high-couture sporting golf brands, overseeing the successful launch of multiple part number programs both on the MX and CH sites with a continual improvement mindset, while actively participating in the operational development of the organization. Designed and deployed a Document Control system which allows the MX collaborators to effectively manage documentation. Management of sinchronized launchs on the MX and CH sites, propitiating a collaboration environment to ensure the implementation of standard practices and a seamless, transparent supply chain solution to customers.Led the R&D team through raw material development and procurement based on a deep understanding of customer needs in terms of product form, fit, function and design for manufacturability.

Led the NPI, Operations and Engineering portion of a new-creation manufacturer of Class I, II and III medical devices. Responsible of the development of turn-key-solution project quotations and accountable of budget management through project development. Implementation of ISO-13485 and FDA-compliant procedures accross the whole organization. Directed multiple projects, leading teams of internal staff and external vendors in delivering business solutions.Assess the organization needs based on new products operational requirements, generating a comprehensive budget plan for project landing and year-over-year price projection for upcoming demand.Perform project tracking through clear and concise status reports; proactively identify potential issues and track project member progress against commitments and defined milestones.Responsible for the creation and maintenance of multiple operating procedures through the whole organization, including Warehouse, Quality, Maintenance, Customs & Compliance, Engineering and Facilities.Operational leadership and support during contract negotiation to close a $10-million project, including full design of end-to-end logistics and manufacturing processes. Project development for phased expansion to achieve a 200% increase in production over a period of 2 years.Implementation of an ISO-13485 and FDA compliant Quality System, with active participation in multiple successful audits by customers and regulatory bodies.Interaction with compliance on importation and exportation, maquiladora program, IMMEX, etc., leading the engineering portion and providing support to other departments.Customer facing and main point of contact for 15+ accounts

Led multiple NPI projects with a holistic approach, focusing on fulfilling the organization needs to appropriately host diverse production processes. Key resource on helping the company broaden its capabilities spectrum, introducing laser-marking and radio-frequency sealing processes.Developed a mass-production process for a complex kidney-monitoring system, increasing the production rate by an 800% upon transfer from the R&D site to the production facility.Responsible for the procurement and purchase of a laser-marking machine, coordinating facilities accommodations and personnel training for a secure and efficient operation.Led the deployment of a phased methodology for introduction of new products, creating a streamlined workflow that allowed the organization to consistently meet defined milestones and operate within compliance guidelines.

Responsible of the Inhaled Anesthesia Administration Device Business Unit, leading and executing the introduction of customized kits requested by end-customers and hospitals. Led the deploymenf of a UDI compliant system, coordinating the update of 450+ production codes through a collaborative effort with customer service, based on forecast and resource availability.

Led the New Product Launch portion for the Vascular division, with a focus on expanding the product catalogue based on final customer needs. Coordination of a cross-functional team to satisfy system needs, from supply chain to order fulfillment of sterilized product. Interaction with customs requirements on both sides of the border, generating a clean operation within the IMMEX and Maquiladora program guidelines.

Assistance on the analysis of engineering changes during Product Development, with a key role of linking the Operations team with the Design site, being responsible of coordinating prototype runs, to present performance and capability reports for the Advanced Engineering staff.