Engineering

NANCY HIDALGO

Ovideo, FL ***** 386-***-****

www.linkedin.com/in/nancyhidalgo16 ********@*********.*** SUMMARY

Experienced Industrial Mechanical Engineer with proven track record in Quality, Manufacturing, Test, V&V, Sustaining and Process Engineering in product development and manufacturing in advanced technologies for medical and pharmaceutical devices, robotics and automation equipment, packaging and semiconductor industries. Qualify engineering professional with high level of attention to detail. Expertise included:

NCR/CAPA process. Closed loop corrective

action system. FDA Compliance

Medical devices quality system, with ISO 13485

and cGMP manufacturing experience, FMEA

Engineering Change Order (ECO) process for

medical devices, ECO Log

Quality assurance and quality control

Updating the engineering bill of materials,

device configuration control, document control

and routing ECOs for review and approval

Engineering drawings interpretation & creation,

release and archiving, change control process

Knowledge of six sigma and lean principles

Project data management system (PDM) to

support configuration management, field

service, manufacturing and product test areas

3D CAD SolidWorks inspection. Automated

creation of balloon drawings and quality

inspection reports for all incoming product.

Computer-aided drafting AutoCAD software

Creation of equipment installation layout

drawing (IntelliFill i.v. medical device)

Problem solver and self motivated, with good

communication skills

Strong organizational skills. Multitask, ability to work on several projects simultaneously

Cross-functional team leadership

Maintaining the calibration system for all

calibrated instruments that were used for design

control, validation and incoming inspection.

Use of calibrated instruments to perform the

GD&T inspection process and quality control.

Customer complaints investigation, supplier

quality and qualification process

Medical devices validation & verification

TrackWise 8 Superuser, QST, TeamCenter

Unified (TcU), Baxter Product Lifecycle

Management, (BPLM), QuickBase, Share Point,

MS Office, MRP

PROFESSIONAL EXPERIENCE

BAXTER HEALTHCARE CORPORATION, Daytona Beach, FL 2011 – 2015 Senior Engineer

Conducted CAPA, continuous improvement, audit, quality systems and assurance, etc.

Interacted with supplier for failure analysis report for components such as Supplier Corrective Action report as part of NCR and CAPA system.

Inspected performance of mechanical, electrical components, assemblies, equipment and tools to verify their efficiency, and investigates and initiated corrective action of problems and deficiencies to ensure product quality.

Performed the migration of IntelliFill i.v. device pdf format drawings to Baxter Product Lifecycle Management, (BPLM) application.

Conducted the quality assessment and quality impact tasks of the Change Control Management (CCM) application for DoseEdge Pharmacy Workflow Management and IntelliFill i.v. products.

Coordinated, scheduled and planned annual calibration instruments and equipment of IntelliFill i.v. devices to meet deadlines. Led the migration activities of IntelliFill i.v. calibration instruments and equipment into Tampa Bay calibration management application.

Coordinated the local hold product process, the initiation, holding and product disposition documentation.

Updated SolidWorks Enterprise Product Data Management (EPDM) per CCM released CAD files. Provided effective support to engineering with 2D/3D AutoCAD and SolidWorks files as needed.

Performed the document control specialist CS3 final release documents for DoseEdge and Intellifill i.v. device in the new system TcU application as needed. NANCY HIDALGO Page 2

386-***-**** ********@*********.***

Coordinated the Corporate Audit response system tasks in the Baxter QST application for IntelliFill i.v. device calibration instruments overdue and incoming inspection Last Time Buy parts OOS.

Conducted review and approval of DoseEdge and IntelliFill i.v. configuration documents.

Performed IntelliFill i.v. device customer complaints as needed. BAXA CORPORATION, Daytona Beach, FL 2009 – 2011

Quality Engineer II

Provided effective support in the Configuration Management for delivering products that meet customer requirements and built according to approved engineering design documentation.

Provided effective support in all the stages of engineering design change process and document control.

Coordinated the new part numbers & Engineering Chance Notice (ECN) numbers in the tracking system.

Generated new corrective action ECN to correct engineering documentation and drawings errors, to update product development specifications and to generate new spare and replacement parts for manufacturing part obsolesce.

Coordinated the instruments and equipment calibration for the IntelliFill i.v. device & vendor’s approval

Performed responsibilities of supporting the Device History Record (DHR) documentation process for the refurbishment of IntelliFill i.v. devices installed at inpatient pharmacy’s hospitals customer site. FORHEALTH TECHNOLOGIES INC., Daytona Beach, FL 2004 – 2009 Quality Assurance Engineer

Responsible for Principles of Lean Documents and Lean Configuration: Design History Files (DHF), Design Master Record (DMR) and Design History Record (DHR) for IntelliFill i.v. device.

Engineering & Manufacturing Document Control Coordinator. Responsible to generate the new part numbers and updating the BOM, once the ECN was released into the document control tracking system.

Led the SolidWorks files lifecycle changes within the PDMWorks docs management control system.

Checked into PDM vault system the electronic SolidWorks & AutoCAD 3D models & 2D drawings files.

Created, scanned and maintained the ECNs folder for engineering, technical support and manufacturing.

Generated & updated the production released engineering drawings in PDF format as ongoing process.

Conducted the design transfer process of IntelliFill i.v., ECNs, specifications and procedures and documents to the manufacturer vendors, contractors Robot Design, Delphi and S&S as needed.

Supported R&D, manufacturing, purchasing and field services engineering teams with released ECNs.

Created the installation layout drawings & ECNs to support sales and implementation management staff.

Supported the AutoCAD drawings creation and revise files to the electrical engineering team as needed.

Responsible for maintaining the standard library references for hardware components.

Trained to support FDA inspections and audits for IntelliFill i.v. medical device. SEGO ROBOTICS, Livermore, CA 2001 – 2004

Manufacturing/Quality Engineer

Coordinated product development with engineering design, testing and production staff to ensure all parts and automation assemblies are built to meet specifications, from component selection throughout product delivery and installation at customer’s sites per semiconductor industry quality and process standards.

Performed manufacturing engineering, quality assurance and quality control inspection tasks to be in compliance with the company quality procedures, product reliability and ISO 9000 standards. EDUCATION

MSIE, BSIE. Industrial Mechanical Engineering College. Advanced Technology Engineering Institute of Tashkent, USSR

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