Process Engineer with a proven track record at Medtronic, excelling in process validation and equipment optimization. Adept in SolidWorks and skilled in problem-solving, I enhance manufacturing efficiency while ensuring compliance with regulatory standards. My adaptability and strong organizational skills drive successful project execution and continuous improvement in medical device manufacturing.
Overview
8
8
years of professional experience
Work History
Process Engineer
Ultimate Solutions / Ethicon, LLC
San Lorenzo
04.2024 - Current
Work with construction suppliers to create quotations and coordinate their work on-site, ensuring that projects are executed according to specifications and timelines.
Consult, create, and discuss work permits using the Enablon platform, ensuring compliance with safety and regulatory standards.
Managed decommissioning, relocation, and introduction of manufacturing equipment.
Collaborate with suppliers to construct duplicates of manufacturing equipment, incorporating enhancements to improve functionality and efficiency.
Design prototypes for Kanban systems and fixtures using SolidWorks to streamline manufacturing processes and optimize workflow.
Collaborate to optimize processes for the introduction of new products, ensuring compliance with regulatory standards.
Support an IQ-CSV protocol for HEMO Packaging Cartoner, ensuring that all necessary validation steps are properly documented.
Engineering Specialist
Medtronic
Juncos
11.2020 - 08.2023
Supported and validated processes and systems for new and existing equipment (IQ, TMV, OQ, PQ) and conducted change order generation in an AGILE environment.
Assessed operators on process changes and ensured equipment attributes were verified across manufacturing sites.
Validated tools, fixtures, and other manufacturing aids using test method validation and documented all activities adhering to Good Manufacturing Practices (GMP).
Assisted in troubleshooting custom equipment and managed documentation related to equipment and product status within a computerized maintenance system (SAP).
Reviewed and generated Preventive Maintenance, Work Instructions, and SOPs.
Associate Engineering Specialist
Medtronic
Juncos
04.2018 - 04.2020
Supported process validation and re-layout activities, including CAPA planning and execution of reworks.
Inspected non-conformance products for release and verified manufacturing processes in the factory talk system (MES).
Assisted in equipment troubleshooting and calibrations, ensuring compliance with documentation and GMP standards.
Demonstrated expertise in supporting operations during non-standard shifts, including weekends and holidays.
Validated equipment mainly tools and fixtures using tooling and fixturing verification.
Social Worker III at County of Santa Clara, Department of Family & Children’s ServicesSocial Worker III at County of Santa Clara, Department of Family & Children’s Services