Antonio Araiza

March 2023 – Today

Current Company: Baxter

Position: Sr. Project Engineer /Transfer

Lead a product transfer from Milwaukee, WI, to Tijuana Mexico of three families of finished products, performing activities such as:

• Developing detailed timelines for each of the product families being transferred.

• Establishing engineering deliverables and collaborating with the departments involved to set up their corresponding activities.

• Coordinating trips to Milwaukee for multifunctional teams.

• Organizing and designing the training plan for production personnel.

• Establishing effective communication channels with different departments and the sending site.

• Supervising and coordinating project engineering activities.

• Managing the acquisition of equipment, tools, and infrastructure for production stations.

• Developing detailed plans for transfer validations.

• Communication of project status and escalations to upper management

January 2015 to March 2023

Current Company: Medtronic (Nellcor Puritan Bennett)

Position: Sr. Project Engineer 

Activities:

•    Work as a project engineer in two product transfers.

•    Coordinate engineering activities with suppliers for raw materials validation.

•    Manage projects from planning, testing to implementation phase.

•    Execution of engineering activities for projects such as validations & engineering runs.

•    Lead projects in areas of hi-impact.

•    Create a core team with Sourcing, Regulatory, R&D, Design Quality, Planning and Production to coordinate and execute each of the project activities.

•    Manage budgets for different project accounts.

Achievements:

•    Work in a product transfer leading activities such as clean room modifications, management of construction capital, cool room construction, equipment installation, layout creation, production stations design, equipment validations, DOE, OQ and PQ execution, travel to Costa Rica to be trained in process, travel with production employees to train them in the assembly process. 

•    Work in a product transfer from Irvine lading activities such as clean room utilities installation for the manufacturing line, equipment installation and perform applicable qualifications. Transfer timeline creation, determine with team the project deliverables, capital and expense management, coordinate project deliverables with team.

•    Validation of a new needle assembly to reduce a potential Backorder of 460k per year.

•    Validate a new component of the Oximetry Sensor to prevent a cost increment of 400K and have an annual saving of 200k.

•    Validate a new supplier mold to prevent 100K impact per month.

•    Validate a new supplier of stopcocks to prevent a backorder issue of 50K per month.

•    New tool validation that affects all production area, higher revenue area of the plant to prevent service issues.

November 2011 to January 2015.

Previous Company: Flextronics Medical

Position: Project Engineering / Manufacturing Engineer

Activities:

•     Lead engineering projects.

•     Coordinate manufacturing activities in production floor.

•     Coordinate engineering activities with customer.

•     Creation and execution of Protocols for Process Validations like:  IQ (Installation Qualification), OQ (Operation Qualification), and PQ (Product/Process Qualification).

•     Engineering Technical Evaluation for Medical Devices (Clinical Builds, pilot runs)   

•     Create Risk Documents (Risk Assessments, FMEA, and Control Plans) to mitigate impacts to the process. 

•     Support on customer requirements and complaints for medical companies (Covidien, KCI, Abbott, Bracco Diagnostics Inc., Johnson and Johnson)