Leonardo F. Martínez Estrada Email & Phone Number

Tijuana, B.C., Mx

Tijuana, Baja California, Mexico

• Support the production process of Vascular Introducers and Catheters for compliance with the established metrics, customer and regulatory requirements, and solving quality issues.• Lead projects related to product specification changes, supplier changes and scrap reduction. • Lead projects of production line duplication (operations, fixtures, layout distribution) due to capacity increase.• Elaboration and execution of validations: Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), and Engineering Studies (ES).• Responsible for production line capacity (equipment utilization, headcount, line balance, and shifts) based on customer demand and equipment constrictions.• Creation and modification of Item Master (IM’s), Routings, BOM’s, and Customer Cross References.• Lead and follow-up actions derived from the Quality System as NCRs, CAPA's, NCs, and Complaints. Experienced with FDA inspections and COFREPRIS audits as document reviewer.• Development, training and implementation of CR (Change Records), Deviations (Temporary Authorities) and Quality Alerts.• Creation and update of documents: instructions and quality procedures (INS and PROs), forms (FRMs) and equipment preventive maintenance (PMs).• Handling of Oracle System: Routes, Unit Cost, BOM, WIP Reports, Materials Transactions, Cross Reference.• Participation in Kaizen events related to reduction of downtimes in molding set-ups (applying SMED techniques).• Others: communication/meetings with suppliers, customers and PLT managers; provide feedback to production associates; perform inventories of fixtures and materials; calibration failure reports and support in the implementation of 5s.

Tijuana, Baja California, México

• Investigation and execution of daily activities to solve scrap and issues of the line production of class III medical device called Implantable Pulse Generator (IPG).• Experience in sanding and polishing process, epoxy resin molding process and silicone subassembly processes.• Scrap rate reduction of the IPG production from 7.63% (2021) to 4.15% (2022) of COGP (financial impact $1.04M USD).• FPY increase of the IPG epoxy process from 37.4% (2021) to 70% (2022) with an improvement of 54%.• Lead problem solving project (using A3 format) focused on scrap reduction with cost avoidance of $57k dlls (damaged charging coil) and $50k dlls (sanded weld seam) in 2022. • Co-leader in automation projects for the improvement of a manual epoxy molding process.• Elaboration and execution of validations: ES and IQ.• Lead and follow-up actions derived from the Quality System as NCRs, CAPA's, Complaints and Audits.• Support in activities to increase cleanroom capacity due to particle counting issues.• Participation in Kaizen events related to ergonomics improvements in the polishing process.• Creation and update of procedures, forms, IM’s, Routings, and BOM’s.

Tijuana, Baja California, México

• Support under limited supervision, to the engineering team in several activities and production related issues of the IPG devices.• Elaboration and execution of validation reports (IQ’s). Support in Engineering Study (ES) related to the change of raw material in the product.• Creation and update of procedures, forms, IM’s, Routings, and BOM’s.• Participation in updating the Value Stream Mapping (VSM) and activities related to CAPAs.• Others: provide training, perform inventories of fixtures and materials, calibration failure reports, and time keeping of processes.

Tijuana, Baja California, Mexico

Professor of undergraduate programs of the following courses:• Introduction to Biomedical Engineering.• Biomedical Instrumentation Systems.

Tijuana, Baja California, Mexico

• Creation of general competencies, general objectives, and the curriculum map of the bachelor of Bioengineering in Manufacturing Processes.• Creation of study programs for the bachelor of Bioengineering in Manufacturing Processes focused on the medical devices manufacturing industry of the regional cluster.

Ciudad De Tijuana, Baja California, México

• Support to Sr. Quality Assurance Engineer in Biopsy Needles Transfer Project from BD (Becton Dickinson) to Merit Medical Tijuana.• Creation and translation of documents: Quality Assurance Procedures (QAP’s) and Purchased Part Inspection Forms (PPIF’s) for Biopsy Needles Devices.• Creation of Engineering Changes (ECNs) in the Oracle system for initial release and revisions of PPIF's, Purchased Part Specification (PPS), QAP’s, fixtures and drawings. • Register several types of measurement equipment/fixtures in the calibration system.• Provide training to inspectors and QA personnel in new quality procedures and forms.

Ciudad De Tijuana, Baja California, México

• Supervision tours of medical equipment in different areas of the hospital.• Preventive maintenance of certain medical equipment.• Offer training for use of different medical equipment to hospital nurses.• Realization of medical equipment inventories into the hospital.• Completion of entry/exit forms of medical equipment into the hospital.

Bachelor Of Biomedical Engineering, Biomedical/Medical Engineering

• Professional Certificate (cédula profesional): #11779609. • Specialty: Industrial Manufacturing. • Residence Project: "Nonlinear.

Master Of Engineering Science

• Professional Certificate (cédula profesional): #12656605. • Subject Area: Dynamical Systems and Control (Biomathematics). • Dissertation.

Diploma In Medical Manufacturing Engineering, Medical Industry

Specialization of human resources through academic training and update on processes and tools used in the manufacture of medical devices.