Dynamic engineering professional with a strong background in project management and component lifecycle management. Skilled in coordinating cross-functional teams, developing engineering documentation, and driving compliance initiatives. Committed to delivering high-quality engineering solutions that meet regulatory standards.
Overview
18
18
years of professional experience
Work History
LCM Component Engineer (Project Lead)
Johnson & Johnson
Cd. Juarez, Chihuahua
12.2020 - Current
Team member of LCM, Irvine, CA, located in Cd. Juárez, Chihuahua.
New ISO Luer 80369-7 compliance implementation for new female connectors.
Collaborate on the development to redesign new molds and tooling for the new luer connector prototypes, ensuring final product quality and functionality.
Work closely with Regulatory Affairs to develop and implement strategies for FDA submission, facilitating the approval process for new products.
Participated in the revision and updates of product documentation to meet MDR EU regulation transitioning from MDD requirements to ensure compliance.
Evaluated component specifications to ensure compliance with industry standards.
Collaborated with cross-functional R&D teams to develop product requirements and designs and also update risk management documentation including DFMEA, PFMEA, AFMEA, traceability matrix ensuring be in compliance with regulatory requirements .
Conducted failure analysis on components to identify the root causes of issues.
Managed component lifecycle documentation and change management processes.
Reviewed supplier performance and material quality for compliance with specifications.
Coordinated testing protocols to validate component functionality and reliability.
Led project planning and execution for engineering initiatives in various sectors.
Coordinated cross-functional teams to ensure alignment on project objectives and timelines.
Facilitated communication between stakeholders to address project challenges effectively.
Maintained the project schedule by monitoring project progress, coordinating activities, and resolving problems.
Managed resources such as equipment, materials, personnel, and subcontractors to achieve project goals.
Coordinated with team members to ensure the timely completion of tasks.
Developed project plans, budgets, and timelines to ensure the successful completion of projects.
Utilized mathematical skills and an understanding of engineering principles to design new products.
Operations Production Lead
Becton Dickinson
El Paso, Texas
08.2020 - 11.2020
Coordinated workflow among team members to optimize production efficiency.
Monitored inventory levels and requested supplies to maintain production flow.
Conducted quality inspections on finished products to uphold company standards.
Managed scheduling of shifts to align with production demands and workforce availability.
Managed multiple projects simultaneously under tight deadlines.
Coordinated daily operations activities to ensure maximum efficiency and productivity.
Conducted regular meetings with staff to discuss production goals, objectives and progress.
Maintained accurate records of inventory levels, resources utilization, job costs and other key metrics.
Assisted with budgeting responsibilities including forecasting future needs.
Staff Validation Engineer (Site transfer Project)
Johnson & Johnson
Fremont, California
10.2018 - 10.2019
Developed and executed validation protocols for medical device manufacturing processes.
Developed and executed validation protocols for medical devices and processes.
Reviewed and approved validation documentation for accuracy and completeness.
Trained junior engineers on best practices in validation procedures.
Led risk assessments to identify potential issues in validation activities.
Prepared traceability matrices to ensure traceability of system components.
Developed validation protocols for process equipment and systems.
Reviewed engineering drawings and specifications for accuracy in validation documentation.
Created detailed reports documenting results from validations activities.
Investigated equipment failures, identified causes, and initiated methods to resolve such issues.
Verified that all systems were functioning according to design parameters through testing and inspection.
Validated software applications related to manufacturing operations.
Inspected, calibrated and tested instruments used to manufacture medical devices.
Maintained and calibrated testing equipment to consistently produce reliable results.
Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
Staff Validation Engineer
Cordis Cardinal Health
Cd Juarez , Chihuahua
03.2016 - 02.2018
Conducted validation activities for medical devices and systems.
Developed and executed test protocols for new product launches.
Reviewed and approved validation documentation for accuracy and completeness.
Identified and resolved issues during the validation process.
Trained team members on validation procedures and best practices.
Participated in audits to verify adherence to regulatory requirements.
Developed validation protocols for process equipment and systems.
Provided technical support in the development of test plans, protocols, reports, SOPs.
Reviewed engineering drawings and specifications for accuracy in validation documentation.
Inspected, calibrated and tested instruments used to manufacture medical devices.
Documented entire validation process and recorded all changes.
Identified safety issues and performance trends by performing statistical analysis.
Collaborated with production team members to help team create and deliver high quality, cutting-edge products.
Senior Manufacturing Engineer
3M Healthcare EDUMEX
Cd. Juarez., Chihuahua, MX
08.2007 - 03.2016
Apply Lean Six Sigma Green Belt certification to drive process improvement initiatives to enhance manufacturing efficiency and quality.
Mentored junior engineers in manufacturing best practices and troubleshooting techniques.
Collaborated with cross-functional teams to design and implement new production lines.
New equipment evaluation transferring activities.
Analyzed production data to identify trends and recommend process adjustments.
Evaluated and selected suppliers for materials to ensure compliance with standards.
Analyzed production data and identified areas of improvement for increased efficiency in the manufacturing process.
Collaborated with suppliers to source materials at competitive prices while maintaining quality requirements.
Implemented Lean Manufacturing techniques such as Kaizen events throughout the facility resulting in reduced waste and improved productivity.
Medical Science Liaison – Urogenital Tumors at Johnson & Johnson Innovative MedicineMedical Science Liaison – Urogenital Tumors at Johnson & Johnson Innovative Medicine
Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)Operations Recruitment Manager - Patient & Site Engagement at ICON Clinical Research (in partnership with Johnson & Johnson)