Enthusiastic and dynamic professional with hands on experience at medical validation protocols (IQ, OQ, PQ), mechanical design, best practices in drawings (GD&T), programming, and lean methodology, aimed at enhancing process effectiveness as well to reach high level of professional & personal development.
Overview
2
2
years of professional experience
1
1
Certification
Work History
Principal Engineering Technician
Biosense Webster Inc. - Johnson & Johnson
11.2023 - Current
Develop and execute validation protocols and reports for the full implementation of TC Cutter & TC Holder projects. This included creating Validation Assessment Protocols (VA), Installation Qualification Protocols (IQ), Manual Operator and Procedures (MOP) documents, Equipment Preventive Maintenance and Repair (EPR) documents, and modifying Process Instructions (PI).
Documentation of Engineering Change Order's (ECO) for drawings and designs for Electrical Testers, Cutting Fixtures and Measuring Templates.
Manage day-to-day interactions with the corporate Design Quality and Engineering teams located in other countries for thorough reviews for specifications and standards. Additionally, manage drawing and design release dates optimally to guarantee a flawless validation process.
Remarkable projects: Led the development of the TC Cutter Fixture and TC Holder Fixture projects, resulting in a 35% reduction in scrap and a 15% improvement in production pieces. Achieved these results by conducting extensive testing with multiple components and fixtures to establish acceptance criteria, and by troubleshooting fixtures when components did not meet quality standards.
Sr. Validation Technician
BEPC Consulting - Providing Services For BWI
04.2023 - 11.2023
Mechanical designs and technical drawings creation for fixtures, go-no-go-gages, workstations, and mechanisms, following ASME Y14.5 standards and GD&T’s best practices to ensure design optimum functionality.
Collaboration with Design Quality Department to achieve releasing 100% of drawings of the Measuring Templates project in less than 3 months.
Participation on Lean Transformation group responsible for production lines analysis to identify non-value added operations (waste time, loss balance and inspection times), to improve cycle times providing automated solutions and its respective mechanical designs.
Transformation of 50% of a production line into to vertical workstations, (process flow analysis, exploring the associated needs and the physical work to make the required movements and installments), to optimize production floor spaces and improve product process flow.
Process Engineering Intern
Align Technology
09.2022 - 04.2023
Elaboration of validation protocols and associated completion reports for the full functionality of the Department of CSPS (Cleaning-Sorting-Packaging-Shipping) and successfully achieved the Controlled Room Certificate of Compliance.
Full validation for a 342% increase in saleable material.
Experience in controlled rooms required lab testing, validations and ISO, AAMI, USP requirements.
Layouts design for production lines and rearrangements.
Calibrations and Preventive Maintenance management.
Education
Bachelor's Degree in Biomedical Engineering -
Universidad Autonoma De Ciudad Juarez
Ciudad Juarez, Chihuahua, Mexico
05.2024
Skills
Microsoft Office Platforms
Solid Works
GD&T & ASME-Y145
AutoCAD
Python
Minitab
Siemens PLC
AI programming
GDP's
GMP's
Certification
Mathematics Interpretation of Engineering Drawings Trainning by CENALTEC - June to October 2023
Siemens PLC Trainning by Servicios Industiales 3i - March to April 2022
Languages
Spanish
Bilingual or Proficient (C2)
English
Advanced (C1)
French
Elementary (A2)
Timeline
Principal Engineering Technician
Biosense Webster Inc. - Johnson & Johnson
11.2023 - Current
Sr. Validation Technician
BEPC Consulting - Providing Services For BWI
04.2023 - 11.2023
Process Engineering Intern
Align Technology
09.2022 - 04.2023
Bachelor's Degree in Biomedical Engineering -
Universidad Autonoma De Ciudad Juarez
Mathematics Interpretation of Engineering Drawings Trainning by CENALTEC - June to October 2023
Siemens PLC Trainning by Servicios Industiales 3i - March to April 2022
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