Principle technician

Orena Danoa

***** ***** *** **** *** *** • Sunny Isles, FL 33160

Home Phone 305-***-**** • E-mail ******@*****.***

SUMMERY:

Over fifteen years of experience in research and development environment at Cordis Cardiology, a worldwide leader in developing and manufacturing interventional vascular technology. Areas of experience and responsibilities include:

• Manufacturing Processes

• Manufacturing practices

• Create/Modified Documentation

• Prototype Development

• Product, and Competitive Product qualification testing

• Tooling Design and Modification

• Production, and New Product Problem solving

• Set Up Production Assembly Line

• Supervised Builds to Support Products and Studies.

• Involved in Validation for numerous studies.

Software: Excel, Windows, MS Office, Minitab, SolidWorks, Auto Cad, Power Point

PROFESSIONAL EXPERIENCE:

CORDIS A JOHNSON & JOHNSON COMPANY, Miami Lakes, FL 1993-2008

Operator 1993-1994

• Balloon Blowing Operator and balloon Machine Setup

• Micro Infusion Angioplasty Catheters. Involved with the entire process and testing.

Technician I 1994-1995

• Thermodynamic Angioplasty Prototype Catheters- responsible for the entire prototype build, and transferring product to Pilot operation..

Technician II 1995-1996

• Mega and Crossflex new coronary stent design for delivery system. Involved with the balloons development.

Technician III 1996-1997

• Smart Stent product for Endovascular. Manufacturing line technician.

Senior Technician 1997-1999

• BX Velocity and BX Sonic Angioplasty balloon/stent Catheters. Involved with product development.

Principle Technician 1999-2008

• Trinity

• Select+,

• Development and execution of Test Methods that are required by the FDA Guidance for SDS such as: Preconditioning, Delivery, Deployment, and Retraction of the catheters.

• Coating Durability- Participate in the validation of the particle recovery analysis for Coating Durability project

As a principle technician I:

• Supported multiple programs in multiple activities.

• Generated service request, scheduled Pilot resources, and supervised builds to support different studies.

• Involved in the development of Test Methods. Developed, executed, and generated report.

• Helped in the Identified and solved problems occurred before and during Feasibility, Design Verification, and Product Qualification builds for the following projects.

• Supported multiple tasks simultaneously during the builds.

• Involved in tools design and tool’s modification for production and R&D.

• Trained and mentored production/pilot operators on documentation and processes.

BETH ISRAEL FAST FOOD RESTAURANT, New York 1990-1992

Restaurant Owner

CONTEL IPC, Connecticut 1989-1991

PC Board Designer

• Interpret engineer’s drawings into printed circuit boards. Drawings were designed for phones used in the stock market for better and faster communications.

ISRAEL AIRCRAFT INDESTERY, Tel –Aviv, Israel 1980-1991

Draft Person

• Draftsperson for F-16 aircraft project supported by the USA

ISRAELI ARMY, Israel 1975-1977

Secretary / part time Physical Education Trainer

EDUCATION:

B.A, Mechanical & Material Engineering, Florida International University, Miami, FL

2006-2009. Currently in Senior Year- expected to graduate Spring 2010

A.A, Environmental Studies, Miami –Dade Community College, Miami, FL 2001-2004

AWARDS:

Received Awards for:

• Self taught on company program, resulting in saving 5K for the company.

• Independently setting up the clean room assembly line for Thermodynamic Angioplasty balloon catheter.

• Outstanding performance in meeting the timeline for BX Velocity catheter, and BX IDE design verification builds in the pilot production area despite many technical obstacles along the way.

• Team Excellence Performance awards for Coating Durability for participating in testing to achieve good result and meeting the timeline.

• Team Excellence Performance awards for BX Sonic, and Cypher Select Plus catheters for contributing and meeting the timeline.

• Encore Award for successful validation of the SEM chronic method.

TRAININGS:

• All Johnson &Johnson Law School On Line Trainings.

• Geometric Dimensioning & Tolerance

• Statistical Methods for quality Engineering

• WD Communication writing

LANGUAGES:

English

Hebrew

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