Engineer Design

Youlia Hristova-Djoneva

Rutherford, NJ *****, 201-***-****,

*************@*****.***

Summary: Over 8 years of experience with software controlled respiratory ventilators, electromechanical and plastic medical devices, such as respiratory ventilators, hypodermic syringes, solenoid valves, pressure transducers, pressure switches and bellows:

-Experience with leading teams for completing of projects within specified timeline and objectives;

-Experience with design controls, design verification and validation for molded devices and components;

-Experience with process verification and validation for software controlled respiratory ventilators;

-Experience with Six Sigma Statistical tools for evaluation of high volume injection molded components using Design for Six Sigma Tools and Methodologies such as DOE (Design of experiment), IVP (Individual value plot), Main Effect Plots, Gage R & R, Pareto charts of the effects, Regression analysis, sampling plans and few transformations;

-Experience with design, redesign, prototyping, testing and variety of calculations for different products;

-Experience with design of fixtures for testing and production;

-Good understanding of GD&T, tolerance stuck-ups and design for manufacturability for machined, milled injection and compression molded parts;

-Experience with non-conforming components - material properties and form, fit and function;

-Extensive experience in writing procedures such as test, specifications, assembly, operating, in-process inspections, final process inspection and sterilization procedures for variety of products;

Technical - Highly proficient in current SolidWorks and proficient in Pro/Engineer Wildfire,

skills: - Highly proficient in Excel and Minitab,

- Skills with other software: ANSYS, Pro/Plastic Advisor, Cape Pack, Pro Model, Arena, Matlab, Simulink, MathCAD, Visio, Share Point, Team Foundation Server.

Work Impact Instrumentation, West Caldwell, NJ 01/13 - Present

Experience: Process Engineer

-Developed several process verifications for ventilators, aspirators, testing fixtures and accessories;

-Developed structure/flow chart for several products and led the efforts for release of the products;

-Launch a new remote calibration testing system for precision fluidic device - high flow module (TSI) and led team to release the hardware package and complete the Device Master Record;

-Developed IQ/OQ/PQ (Installation/Operational/Performance Qualifications) including testing and statistical studies for several devices used in the production of the ventilators: Crimp Press, Solvent Dispenser, Digital Hot Plate Pneumatic Press, Input Output Test Fixture and Front Panel Test Fixture;

-Developed several test procedures for testing of the PCBs (Printed Circuit Boards) for 731 Series ventilator;

-Developed several test procedure for testing the whole ventilators: hipot test, electrical safety tests in accordance to IEC 60601-1, Section 8, front panel test, input output test, reset calibration tests etc.

-Designed several fixtures for testing and production;

Valcor, Springfield, NJ 06/08 - 07/09

Mechanical Design Engineer

-Designed family of 4 isolation solenoid valves using SolidWorks 9.0 assuring proper dimensions and tolerances to formulate correct vertical and horizontal tolerance stuck up, implemented GD&T, welding and design for manufacturability principles;

-Designed/redesigned few valves, a manifold and a fluidic device;

-Designed and tested a high-temperature solenoid valve/body;

-Calculations of springs, conning, threads selection with MathCAD;

-Wrote technical documentation complaint with ISO 9001:2000, SAE, MIL standards;

-Designed several fixtures for the testing and assembly of the solenoid valves;

BD, Franklin Lakes, NJ 05/07 - 05/08

Mechanical Design Engineer in Medical Surgical Systems

-Developed design verification for hypodermic syringe to comply with two ISO standards – ISO 7886-1 & 2 for manual use and for power-driven pump use including statistical study for several dimensions in Minitab; calculation for the volume tolerances based on scale and internal diameter accuracy and to be compliant with ISO 7886-3. Based on these changes, the existing mold was reworked, new samples were molded and another statistical study of the newly molded samples was performed, which confirmed that the design changes will assure compliance with the standards and also better functional performance in the pump;

Additionally, developed several procedures compliant with the fundamental metrological methods and equipment used for measuring the above mentioned dimensions and to comply with ISO 13485.

-Developed initial non-destructive bubble point test and test procedure for confirming the pore size of the filter integrated in the needle hub that confirms filter’s retaining capability vs. other alternative test.

-Supported the molding validation for several plastic components - the requirement was to determine if the Critical To Quality characteristics of the components are within the required limits as a result of the established in the PQ runs process parameters. To determine this, several statistical tools were applied such as DOE factorial design study of the main process molding parameters and then the results were evaluated using the Main Effect Plots, Gage R & R and Pareto charts of the effects;

Additionally, supported several quality control specifications: Process inspection and stat sampling using ISO 2859-1 or ANSI Z1.9 sampling plan for few subassemblies; Test procedure for volume measuring and calculating, and to comply with ISO 8537, Test procedure for luer tip taper gauge method, Operational procedure for component’s preparation - washing and lubrication before assembly; Buy spec for sterilization, Buy spec for plastic material modification and many others.

-Performed Shelf Life Statistical Analysis in Minitab of several plastic components that were tested for Real time and Accelerated aging after sterilization as part of the requirements for support of expiration date claims for medical devices and to comply with ASTM F 1980-02.

ASCO Valve, Inc., Florham Park, NJ 04/06 – 05/07

New Product Development Engineer

-Designed micro miniature valve in Pro/E Wildfire 2.0 & calculated the coil; did tolerance analysis;

-Designed pinch valve - calculated the solenoid coil; redesign the manual override in a molded body;

-Designed fill and purge helium manifold for inflating and deflating the stent for the heart;

-Redesigned rocker valve mechanism to allow for minor parts variations of over molded insert through accurate tolerance analysis, updated several critical dimensions and tolerances, and put in place procedure for mold maintenance;

-Redesigned several coils to comply with RoHS/WEEE;

-Modeling and simulation of solenoid valve and uncertainty study using Monte Carlo method with Simulink;

-Electromagnetic simulation of solenoid valve with ANSYS;

-Simulation of Molding Process with Pro/Plastic Advisor;

-Simulation of Dynamic System with Simulink;

ASCO Scientific, Florham Park, NJ 06/05 – 04/06

Sustaining Engineer

-Dealt with non-conforming components - Developed standard assembly, testing and operating procedures; performed several tests, studies, tolerance analysis; updated several dimensions, tolerances and GD&T in the existing drawings in Pro/E Wildfire 2.0;

-Executed Statistical Process Control study to determine the seat leakage of rocker and micro miniature direct acting valves. Tested with mass spectrometer Varian tracing helium to evaluate the valves and verified compliance with Class 5, Type B of Fluid Controls Institute – FCI 91-2-2001.

Sigma-Netics, Inc., Fairfield, NJ 05/04 – 09/04

Assistant Engineer, Design and Product Development

-Designed tester for temperature testing of bellows in SolidWorks - all models and drawings, tolerance analysis and GD&T;

-Prepared and conducted several temperature tests for several pressure switches in environmental chamber to characterize their performance - actuation and de-actuation point with pressure gages;

-Designed several production fixtures for assembly and testing of the pressure switches: fixture for pressure switch characterization, fixture for testing the deflection of sensing pressure diaphragm and fixture for epoxy applying;

-Updated and organized safety documentation database with MSDS for adhesives, lubricants and others;

-Simulation of Manufacturing Process of Drilling with Arena.

Education: Stevens Institute of Technology, Hoboken, NJ, Graduated in May 2006

Master of Engineering in Mechanical Engineering, GPA: 3.6

Pharmaceutical and Medical Device Manufacturing Practices Certificate

Technical University, Sofia, Bulgaria, May 1996

Master & Bachelor of Mechanical Engineering – Precision Mechanical Device Design, Optical & Laser Technology, Metrology & Measurement Equipment, Medical equipment

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