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ROBERT PINKUL

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Process Development Engineering & Design Specialist

Supporting the Medical Device Industry

ENGINEERING PROJECT HIGHLIGHTS
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PROFESSIONAL PROFILE

 

 

 

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Throughout my career, I've had the pleasure of working alongside a diverse group of medical device manufacturers ranging from early-stage, venture-backed startups to globally recognized Fortune 500 corporations. My career has centered on delivering high-value electro-mechanical design expertise and advanced process automation solutions that support both R&D initiatives and full-scale production environments. I bring cross-disciplinary expertise into the unique technical, regulatory, and operational demands of Class I, II, and III medical devices, ensuring that every solution I develop strengthens product quality, manufacturability, and reliability.

 

I specialize in designing and implementing innovative manufacturing and test systems that enable companies to scale efficiently while maintaining strict engineering and quality standards. From early concept development through full project implementation, I manage the complete lifecycle of custom equipment, fixtures, automated systems, and integrated test solutions. My hands-on engineering approach is grounded in strong attention to technical detail, cross-functional collaboration, and an ongoing commitment to continuous improvement.

 

Over the years, I’ve built a reputation as a technical leader capable of diagnosing complex manufacturing challenges, uncovering root causes, and delivering cost-effective solutions that improve yields, increase throughput, and reduce operational risk. Whether developing automated assembly and test systems, designing custom control interfaces, or supporting validation activities, my goal is always the same: to provide reliable, scalable, and compliant engineering solutions that accelerate product success.

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AREAS OF EXPERTISE

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​     Technical Leadership

     Automated Test & Assembly Systems

     Custom Laboratory & R&D Equipment

     Manual and Automated Fixture Design

     Integration of A.I. Tools into Process Engineering Workflows

     Reliability Engineering & Yield Improvement

     Cost Reduction Strategies

     Vendor Qualification

     Process Validation Support (IQ, OQ, PQ)

     Technical Documentation & Engineering Reports

     Control System & Electrical Schematic Design

     Data Acquisition Systems

     PLC Programming (Ladder Logic)

     Custom Software Interface (LabVIEW)

     Machining & Precision Fabrication

     3D Printing: SLA & Fused Filament Fabrication

     Prototype Mold Design

     SolidWorks & AutoCAD

     Advanced Technical Troubleshooting

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PROFESSIONAL PROFILE

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CLIENT LIST
3M Science_Resized.jpg
Micro Therapeutics_Resized.jpg
Radiance Medical Systems_Resized.jpg
Edwards Lifesciences_Resized.jpg
Medtronic_Resized.jpg
Becton Dickinson_Resized.jpg
Johnson and Johnson_Resized.jpg
Merit Medical Systems_Resized.jpg
JenaValve_Resized.jpg
Micra Pro_Resized.jpg
USGI Medical_Resized.jpg
Smith&Nephew_Resized.jpg
C. R. Bard_Resized.jpg
Geiger Medical Technologies_Resized.jpg
Endologix_Resized.jpg
Arbor Surgical_Resized.jpg
Boston Scientific_Resized.jpg
Sub-Q Medical_Resized.jpg
Applied Medical_Resized.jpg

 

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JenaValve Technology, Inc. - Irvine, CA.
Transcatheter Aortic Valve Replacement (TAVR) for severe aortic
regurgitation and stenosis


Johnson & Johnson, Corp., 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

Boston Scientific, Corp., Guidant, Corp. - Menlo Park, CA.
Surgical devices for cardio-thoracic and OBGYN surgery, catheters, trocar

Becton Dickinson and Co., Luther Medical Products, Inc. - Tustin, CA.
Intravascular catheters, split needle cannula, devices for vascular access
and infusion therapy


Arbor Surgical Technologies, 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

EV3 Neurovascular, Inc., Micro Therapeutics, Inc. - Irvine, CA.
Infusion catheters, guidewire

USGI Medical - San Clemente, CA.
Endoscopic access device, suture anchors

CR Bard, Inc., Venetech Intl., Inc. - San Diego, CA.
Intravascular catheter securement system, IV fluid transfer unit

Micra-Pro, Inc. - Paradise, CA.
Micro abrasive dental polishing disk

Geiger Medical Technologies - Monarch Beach, CA.
Handheld cauterizing device

CLIENT COMPANY PROFILES

PROJECT WORKFLOW

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​​My approach to medical device process development is grounded in engineering partnership rather than product sales. I provide specialized engineering and design services, billed on an hourly basis, to help organizations develop, refine, and validate their manufacturing and testing processes. Equipment and fixtures are custom designed for specific client projects and are not marketed or sold as standalone products. This model allows clients to retain full ownership and control of all project hardware and expenses, with items such as machining, metal processing, components, and assembly or troubleshooting activities procured directly through the client’s facility or approved suppliers. Project workflows are intentionally flexible and are tailored to the scope, technical risk, and regulatory complexity of each engagement, ensuring that the development process aligns with both practical manufacturing needs and quality system requirements.

PROJECT WORKFLOW
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WELCOME TO YOUR

PROJECT PORTAL

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This secure space provides centralized access to project schedules, technical documentation, project status updates, â€‹

video call scheduling, and payment processing.

PROJECT PORTAL

CONTACT

Robert Pinkul
  Asheville, NC. 28806

rapinkul@gmail.com
(828) 962-3439

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