RYAN DAULTON
ORANGE
Summary
R&D / NPD engineering leader (16+ years) delivering implantable and catheter-based medical devices from concept through GLP/preclinical, verification, and global submissions (510(k), PMA, CE Mark). Deep experience in structural heart (TAVR), cardiovascular, peripheral vascular, and neurovascular across Edwards, Foldax, Medtronic, and Stryker. Built and led cross-functional teams (R&D, Quality, Manufacturing, Regulatory, Clinical) to set strategy, de-risk programs, and deliver launch-ready designs. Proven track record in leading multidisciplinary engineering teams to develop advanced steerable catheters, implants, mechatronic systems, and device enclosures. Recognized for inventing market-leading products and fostering strong collaborations with physicians to drive device evaluation and continuous improvement.
Overview
19
19
years of professional experience
Work History
Future Tech Leader (R&D)
Stryker Peripheral Vascular
Irvine, CA
01.2025 - Current
- Spearhead formation and direction of the first Advanced R&D team.
- Ideated 10 distinct concepts targeting emerging markets and adjacent solutions.
- Selected top two concepts using Biodesign principles, Physician input, and ensured strategic alignment with Marketing, Regulatory, and Business Development.
- Currently developing top two concepts with small team of engineers and technicians.
- The team successfully demonstrated feasibility of the top two concepts from initial prototypes to animal studies within 12 months.
- Developed novel self-expanding Iliofemoral Nitinol stent.
- Prototyped novel Left Atrial Appendage Closure Device.
- Managed development of novel Embolic Delivery Catheter.
Founder
REV Medical Design Inc.
Irvine, CA
03.2024 - 12.2024
- Design enclosure with multiple electromechanical subsystems for neurovascular thrombectomy device.
- Incorporate pump assembly, lead screw, and HMI Touch screen into one enclosure with EMI shielding to meet IEC 60601-1.
Director of TAVR Development
Foldax
Irvine, CA
12.2018 - 02.2024
- Directed team of R&D, Quality, and Manufacturing Engineers to meet both business needs and personal development goals.
- Presented project updates to key KOLs (ex: Dr. Martin B. Leon, Dr. Isaac George, Dr. Paul Sorajja).
- Led development of polymer heart valve from initial concept to design verification testing to meet ISO 5840 and ISO 13485.
- Designed precision molded parts for dip casting polymer leaflets and completed mold optimization and validation.
- Developed custom PLC driven automated dipping robot for precise dip casting of polymer heart valves (designed linear robot, PLC coding, enclosure layout, wiring).
- Designed and developed complex manufacturing fixtures using pneumatic grips, linear & rotary drivers, ultrasonic cutters, and completed FMEA for manufacturing process.
- Vendor management of US and OUS suppliers for Nitinol and Cobalt Chromium heart valve frames.
- Developed process flow and designed ISO Class 7 cleanroom.
Senior R&D Engineer (AT)
Edwards Lifesciences
Irvine, CA
11.2013 - 12.2018
- Led clinical device preparation at U.S., Canadian, and European hospitals for First in Human (FIH) Device Evaluations.
- Designed and tested Nitinol implants for right ventricle anchoring of tricuspid repair device.
- Designed and developed new molded catheter handle assembly to improve device performance and reliability (deployed in clinical testing).
- Developed multi-flex catheter to deploy nitinol anchors in right ventricle and evaluated device in acute animal studies.
- Developed automated balloon shaping system that enabled on-balloon crimping of heart valve (patented).
Senior R&D Engineer
Medtronic Neurovascular
Irvine, CA
01.2010 - 10.2013
- Project Manager – Apollo Micro Catheter (1st detachable tip micro catheter in U.S.), led team of regulatory, quality, and manufacturing to complete U.S. submission for FDA approval.
- Conducted DOEs to develop and optimize process parameters.
- Improved yield of atherectomy catheter from 69% to 90% by implementing new fixtures, conducting DOEs, and updating procedures.
- Conducted cadaver studies to evaluate new hypotube based catheter.
Research and Development (R&D) Consultant
Shape Medical Systems, Inc.
Irvine, CA
07.2008 - 06.2010
- Designed and packaged the Shape-HF Cardiopulmonary Exercise Testing System – obtained 510K approval.
- Designed injection molded mouth pieces and disposables.
- Packaged Shape-HF system to meet UL 60601 standards (shock/drop, environmental testing, electrical safety, EMI).
Research and Development (R&D) Intern
Abbott Medical Optics
Santa Ana, CA
06.2007 - 05.2008
- Designed components used for ophthalmic surgery equipment.
- Designed and manufactured a more compact, quick assembly, sheet metal housing for a pneumatic control system.
- Utilized FEA analysis to improve design of high fatigue components.
- Designed a novel foot pedal capturing system that accommodates all shapes/sizes of footwear for the Phacoemulsification System user interface (patented).
Education
Biodesign Executive Education -
Stanford University
Stanford, CA03-2026
M.S. - Mechanical Engineering
University of California Irvine
Irvine, CA06-2013
B.S. - Mechanical Engineering, Material Science Engineering
University of California Irvine
Irvine, CA06-2009
Skills
- CERTIFIED SOLIDWORKS PROFESSIONAL
- PRO ENGINEER (CREO)
- PLC CODING
- MINITAB
- MS PROJECT
- MS VISIO
- MATLAB
- LABVIEW
- FINITE ELEMENT ANALYSIS (FEA)
- BIOROBOTICS
Timeline
Future Tech Leader (R&D)
Stryker Peripheral Vascular
01.2025 - Current
Founder
REV Medical Design Inc.
03.2024 - 12.2024
Director of TAVR Development
Foldax
12.2018 - 02.2024
Senior R&D Engineer (AT)
Edwards Lifesciences
11.2013 - 12.2018
Senior R&D Engineer
Medtronic Neurovascular
01.2010 - 10.2013
Research and Development (R&D) Consultant
Shape Medical Systems, Inc.
07.2008 - 06.2010
Research and Development (R&D) Intern
Abbott Medical Optics
06.2007 - 05.2008
M.S. - Mechanical Engineering
University of California Irvine
B.S. - Mechanical Engineering, Material Science Engineering
University of California Irvine
Biodesign Executive Education -
Stanford University
Academic Research
- Paul Merage School of Business, 2009 Business Plan Competition Winner
- Swift Engineering team Project Manager – develop replaceable 3d printed molds for carbon fiber layouts
- UCI Formula Hybrid Race Team – chassis design and IC engine integration engineer
- UCI Formula SAE – body design and chassis integration engineer
- UCI Design/ Build/ Fly Team – fuselage design team
Patents
- Manufacturing of Implantable Polymer Prosthetic Valves (US20210038379A1)
- Device and Methods for Securing a Tissue Anchor (US20190059876A1)
- Tissue Anchoring Handling System and Methods (US20220071620A1)
- Balloon for Prosthetic Valve Delivery Apparatus and Methods of Assembly (US20220226115A1)
- Adjustable Foot Pedal Control for Ophthalmic Surgery (8,749,188)
- Detachable Coupling for Catheter (US 20130338643 A1)
Publications
- Rapid Prototyping: A Cheaper, Faster Manufacturing Method
- California Engineer: Fall 2009