Quality Control Manufacturing

SUMMARY

. Over two years of engineering experience in Biomedical Design,

Manufacturing and Implementation.

. Troubleshooting expertise related to manufacturing material

discrepancies including Tolerance Analysis.

. Proficient in the implementation of ISO 9000 policies and procedures

that are consistent with GMP.

. Excellent communication skills to convert feedback from operators into

a technical problem for analysis.

. Knowledge of Change Notice (CN) and Stop Ship processes related to IVD

devices.

EXPERIENCE

Beckman Coulter Inc, Miami, FL Technical Operations Engineer Nov 2007 - Nov

2009.

. Troubleshoot discrepancies (MR) observed by Incoming Quality Control

(IQC) from a functional standpoint using Tolerance Analysis or

Standard FMEA Tools and Lean Six Sigma principles.

. Contribute to the analysis, design and development of new projects by

providing feedback from a Design for Manufacturing (DFM) perspective

and creation of new documentation such as manufacturing method sheets

(MMS) as needed with correct use of GMP.

. Using product knowledge to create standard Change Release Notices

(CN's) for updating Bill of Material (BOM) into compliance with

company standards for IVD instruments and aid Lean initiatives.

. Use of MRP system to review non-conforming material. Also trigger stop

shipments in the event of a major failure with guidance from the

Quality Control group.

. Interface with external and internal vendors to effect continuous

process improvements (CPI) initiatives that are consistent with Lean

manufacturing techniques and may result in cost reduction.

. Use statistical analysis tools like ANOVA for Design of Experiments

for Configuration management (CM) in order to interpret data from

manufacturing defect databases like IMS to understand pattern or

trends of system's performance.

. Contributed to Kaizen events to improve process efficiency by

characterization of the process to create new workable modules.

Laboratory Technician. Bioheart Inc. (September 2006 - December 2006)

. Performed studies on the effect of electro-stimulation of culture of

myocardial cells by analyzing viability and proliferation with

different levels of electro-stimulation using the Guava Easy-Cyte flow

cytometer.

. Develop customized test protocols to aid researchers for running

specific cell cultures through different dilution rates and eclectic

reagent media.

. Analyze results from data collected in order to delay proliferation of

cells in culture though interpretation of histograms using proper

gating and threshold limits.

. Create day to day clean room manufacturing processes to isolate

myocardial cells under GMP environment under ISO and FDA standards.

EDUCATION

FLORIDA INTERNATIONAL UNIVERSITY (FIU) MIAMI, FLORIDA Aug 2003- April 2007

Bachelor of Science in Biomedical Engineering (BS)

RELEVANT PROJECTS

Prosthetic Aortic Heart Valve Delivery System (Senior Design Project) FIU

Miami

FL. Jan 2006- Dec 2006

Lead a Design team for the development of a fully functional prototype

of a Prosthetic Aortic Heart Valve Percutaneous Delivery System.

Incorporate input from physicians, anatomical requirements and prosthetic

heart

valve specifications, to a manufacturable and marketable prototype.

CERTIFICATIONS

. Six Sigma Green Belt Certified

. SolidWorks 2007

SOFWARE SKILLS

. SolidWorks 2007

. AutoCAD 2004

. Matlab 6.0

. Microsoft Office 2005

PERSONAL SKILLS

. Highly organized, self motivated and committed to achieve set

goals.

. Highly motivated and results-oriented professional.

. Fast learner and starter who quickly assimilates and implements new

processes and procedures.

. Strong writing and problem solving skills with attention to detail.

. Lead team in engineering projects, often noticing what others miss.

. Ability to work on multiple projects concurrently.

. Ability to analyze engineering test data.

. Strong skill in time management, prioritizing tasks and meeting

deadlines.

. Cooperatively work with others to produce and deliver required work

. Languages: Fluently in English, Spanish and French

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