Irma Gutierrez Email & Phone Number

California, United States

Abbott Park, Illinois, Us

• Leading Cross Functional Teams (CFT) through design planning and project management for multiple reliability projects for the Alinity h series instrument. Worked with a CFT as the project manager to deliver, in two weeks, the update of a cyber security manual for the Alinity h series instrument. • Functioned as the Design Plan coordinator for two reliability projects, successfully completing them per schedule.• Creatively developed and manage Integrated Systems lab testing and instrument utilization metrics, for monthly reporting of Right First-Time metrics to the Program Management Organization using Power Bi reports. This metrics help track laboratory testing efficiency. • Successfully created, implemented, and manage an online instrument reservation system for Alinity h-series, using MS form for users to request instruments and Power Automate flows to create automatic notifications for users to return instrument at the end of their reservation. The reservation process has shown great improvement in streamlining instrument usage, and organization and planning, enabling R&D teams to complete their projects on time.• Advanced experience creating Power Bi dashboard reports and Power Bi apps, and Power Automate flows. Quickly gained experience working in various Abbott applications such as Lotus Notes, Abbott Diagnostics Manufacturing System ADMS, Maximo, Abbott Product Lifecycle Management APLM, and Serena Business Management SBM. • Accountable for lab reagents and supplies orders used in the laboratory and updating forecasts when needed.

Abbott Park, Illinois, Us

• Experience in designing and developing device components; for instance, designed a hook to hang the PHP puck from the console that could fit over the cables and inside existing packaging. • Performed a variety of different documentation such as written manufacturing and test instructions, component and fixture CAD drawings, protocols and reports, and equipment calibration and PM procedures.• Conducted device testing, device investigations, and troubleshooting systems. Led the device investigation activities during a characterization study to evaluation the integrity of the PHP device and its readiness for clinical studies and communicated findings to the core team• Coordinated technical personnel, provided training and managed testing schedules to conduct experiment studies of new or enhanced products or processes• Ordered supplies, materials and new equipment needed for testing• Compiled and analyzed data from various tests such as hemolysis test data and device durability for the PHP device using Excel spreadsheets, JMP, etc. • Designed and created a variety of fixtures and specifications used for testing of product. • Managed laboratory equipment and fixturing to ensure equipment compliance to company quality, good performance and readiness to meet testing demands.• Worked with the Systems Engineering group to develop test methods. Developed a saline system pressure test method to test for leaks in the saline path of one device, and modified existing test method to make it more clinically relevant • Created project schedules using Microsoft Project and Microsoft Excel spreadsheets for reporting and communication• Experience in interacted with various departments, Systems Engineering, Quality, EHS, Machine Shop, Purchasing, Regulatory, Clinical, etc, within the organization

Pleasanton, Ca, Us

• Promoted from Sr. R&D Technician to R&D Engineer after completing my BS degree in Mechanical Engineering in July 2017• Responsible for performing hemolysis testing of the PHP device, analyzing data, record observations and communicate findings to the project team• Responsible for managing all R&D instrument’s calibration log and ensure quality compliance and good performance • Managed all laboratory chemicals and disposal by ensuring compliance with EHS policies• Worked with the engineering team to design and develop the impeller component of the Percutaneous Heart Pump catheter by testing many different molding and component materials • Greatly contribute to the development of the impeller manufacturing process • Performed inspection of hundreds of impellers used to build PHP catheters for verification, aging, and other clinical evaluations.• Created manufacturing procedures of the impeller component• Trained engineers and supported the transfer of the impeller manufacturing to St Paul, MN.• Supported the inspection of various components used to manufacture the PHP device• Coordinated the move with facilities of all equipment from Sunnyvale to Santa Clara in 2017 after becoming part of Abbott and managed the equipment qualification, calibration and PM after the move while complying with Abbott Vascular quality system and policies. • Developed a verification protocol to test a new software version of the PHP Console, managed the testing and completed the report.

Strong job progression from Cleanroom assembler to Sr. R&D Technician, in less than five yearsWork with R&D engineers on the design of new products and corporate researchDesign electrosurgical medical device components and assembliesCommunicate with qualified suppliers/vendors to order parts and componentsBuild or assembled prototype materials, components, subassemblies and assembliesPerform tests, data analysis, and writes reports. Design tools and fixtures used in the assembly and testing of electrosurgical medical devicesUsed manufacturing, test, development or diagnostic equipment, including, but not limited to manual machining equipment, oscilloscopes, multimeters, and specialized electrical test apparatus. Use machine shop equipment, sand blasting machine, injection molding, drills, saws, hypotube bending fixtures, etc.Worked from schematics, diagrams, written and verbal descriptions, layouts or defined plans to perform job functions with minimal supervision.Develop and edit processes and manufacturing instruction, and assist in product transfer by training assemblers on manufacture of new devices. Ensuring that proper documentation was implemented to support GMP and EN/ISO 9001 standardsInventor of three patents: 1. System, method and apparatus for electrosurgical instrument with movable fluid delivery sheathPatent number: 83232792. System, method and apparatus for electrosurgical instrument with movable suction sheathPatent number: 83177863. SYSTEM, METHOD AND APPARATUS FOR ELECTROSURGICAL INSTRUMENT WITH MOVABLE FLUID DELIVERY SHEATHPublication number: 20110077646

Bs Mechanical Engineering, Mechanical Design

Aa, Engineering

Education record