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Robert Pinkul
Process Development Engineering/Design Specialist
for the Medical Device Industry
Portfolio
ENGINEERING PROJECT HIGHLIGHTS
Heart Valve Pulse Duplicator
with Data Acquisition
Automated Latex Balloon Dipping
Workstation with Data Acquisition
Automated Catheter Package
Molding Machine
Heart Valve Accelerated Wear Tester
with Data Acquisition
Automated Catheter Drilling Machine
Pulse Duplicator
For Tissue Heart Valves
Trocar Balloon Fatigue Tester
Automated Catheter Tubing Cutter
Slit One Wall and Cut to Length
Adjustable Pressure Pulsatile
Vein Fixation
Automated Suture Device
Functionality Tester
Trocar Assembly Fixture
Automated Breast Tumor Marker
Test System with Data Acquisition
Catheter Balloon Pressure Decay
Tester
Tissue Heart Valve Orifice Area
Analyzer
UV Adhesive Dispense/Cure
Workstation
Automated Split Needle Cannula
Former
Duckbill Check Valve Tester
Heart Valve Destructive
Pulse Duplicator
Adjustable Tension Heart Valve
Stent Cloth Former
Automated Dental Polishing Disk
Assembly
Tissue Heart Valve Static Fixation Rig
Guidewire Teflon Coating Machine
Loop Lumen Electrode Flow Fixture
Microscope Slide Air Dry Chamber
Custom Vacuum Chamber
TAVR Delivery System Assembly Fixture
Radioactive Catheter Balloon
Folding Fixture
Prototype Silicone Bellows Mold
Prototype Catheter Package Mold
Sample Control Schematic
About
Clients
PROFESSIONAL PROFILE
Throughout my career, I've had the pleasure of working with a diverse group of medical device manufacturers with an emphasis on providing electro-mechanical design and process automation expertise. These companies include early stage, venture backed start-ups to established Fortune 500 corporations.
My focus is on developing manufacturing/test solutions to support production, as well as R&D. I specialize in creating technically innovative process solutions for the manufacture/test of Class I, II, & III medical devices while managing all phases of development, from initial concept through project completion.
AREAS OF EXPERTISE
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Technical Leadership
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Automated Test/Assembly
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Custom Lab Equipment
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Manual/Automated Fixture Design
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Reliability and Yield Improvement
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Cost Reduction
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Process Validation Assistance (IQ, OQ, PQ)
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Docs. Package (Solid Model, 2D Drawing, BOM, WI)
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Control System Design (Schematics)
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Data Acquisition
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PLC Programming (Ladder Logic)
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Custom Control Interface (LabVIEW)
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Skilled Machinist
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3D Printing (SLA, Fused Filament Fab)
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Prototype Mold Design
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SolidWorks, AutoCAD
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Technical Troubleshooting
CLIENT COMPANY PROFILES
JenaValve Technology, Inc. - Irvine, CA.
Transcatheter Aortic Valve Replacement (TAVR) for severe aortic
regurgitation and stenosis
Johnson & Johnson, Biosense Webster - Irvine, CA.
Diagnostic and treatment tools for cardiac arrhythmia
Edwards Lifesciences, Corp. - Irvine, CA.
Surgical devices for the treatment of advanced cardiovascular disease
Medtronic, Inc. - Santa Ana, CA.
Cardiac valve prosthesis, tissue
Smith & Nephew PLC., Sports Medicine Division - Irvine, CA.
Suturing device for arthroscopic rotator cuff repair surgery
Merit Medical Systems, Inc., Cianna Medical - Aliso Viejo, CA.
Technologies for early-stage breast cancer treatment
Radiance Medical Systems, Inc. - Irvine, CA.
Intravascular radiation therapy catheter
3M Inc., CDI Division - Tustin, CA.
Blood gas analyzer
Origin Medsystems/Guidant Corp. - Menlo Park, CA.
Surgical devices for cardio-thoracic and OBGYN surgery, catheters, trocar
Luther Medical Products, Inc. - Tustin, CA.
Intravascular catheters, split needle cannula, devices for vascular access
and infusion therapy
Arbor Surgical, Inc. - Irvine, CA.
Cardiac valve prosthesis, tissue
Endologix, Inc. - Irvine, CA.
Aortic aneurysm stent graph catheter delivery system
Applied Medical, Inc. - Rancho Santa Margarita, CA.
Surgical products for general surgery, urology, vascular, cardiac, colorectal
and OBGYN surgery
Sub-Q Medical, Inc. - San Clemente, CA.
Subcutaneous wound management device
Micro Therapeutics, Inc. - Irvine, CA.
Infusion catheters, guidewire
USGI Medical - San Clemente, CA.
Endoscopic guide
Venetech Intl., Inc. - San Diego, CA.
Intravascular catheter holder, IV fluid transfer unit
Micro Pro, Inc. - Paradise, CA.
Micro abrasive dental polishing disk
Geiger Medical Technologies - Monarch Beach, CA.
Handheld cauterizing device
Contact
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