Gustavo has more than 20 years experience as a technician in the medical device industry. He has been involved in equipment design, tooling, installation, troubleshooting, preventive maintenance, and qualification activities for diverse medical device production lines.
- Support all qualification activities for Medical Equipment (IQ).Support all remediation activities for TMVs.
- Support all qualification activities for Medical Diagnostics Environmentally Controlled Rooms (IOQ, PQ for 20 rooms).
- Support all qualification activities for Medical Diagnostics HVAC System (IQ, OQ for 6 AHUs).
- Field verification of all Visala Sensors for all AHUs.
- Reviewed of all drawings for these AHUs and calculated Air Changes.
- Create Documentation, X-Order Numbers, to run orders for a Packaging Remediation.
- Read, interpreted and created charts from Data Loggers: Omega ZED-TH Portable and Kaye ValProbe
- Running various Packaging Testing Equipment:
- Lansmont Drop Test Equipment
- Lansmont Vibration Equipment
- Doing Bubble and Dye Test
- Vinatoru Seal Strength Test Equipment
- Reviewing Protocol Test Results
- Write reports
- Transferred (decommissioned and re-installed) equipment for four domestic production lines to overseas site. Translated all documentation (Manufacturing Procedures and Maintenance Procedures) from English to Spanish. Revised and documented equipment drawings and implemented revised documents in Product Data Management (PDM) system.
- Designed and implemented fixtures and tooling for production equipment.
- Designed production equipment per specifications from manufacturing engineers using SolidWorks and Solid Edge CAD systems and in accordance with the E&AS system.
- Designed and machined new parts for equipment as required.
- Supported engineering teams through design evaluations.
- Responsible for executing equipment qualification protocols (IQ/OQ/PQ) for diverse products.
- Assisted with the redesign of sensor ovens resulting in more stable temperatures, capacity increases, decreased scrap and repair down time.
- Assisted with the design, installed and executed Installation Qualification for new production line.
- Supported multiple Value Improvement Projects that have generated over $1.25 millions in annualized scrap savings.
- Responsible for set-up, maintenance, troubleshooting, and ensuring that all production equipment operates efficiently.
- Guided production technicians on multiple product lines and introduction of new product lines.
- Assisted production engineers to improve production through problem solving (Six Sigma approach).
- Key individual on the lean implementation team for diverse production lines.
- Validation Technician – BioTeknica, Inc.
- Senior Manufacturing Engineering Technician – Boston Scientific
- Production Technician – Boston Scientific
- Degree in Electro/Mechanical Drafting –Center for Employment Training (CET)
- Advanced SolidWorks Training
- Six Sigma: Yellow Belt Training