Jordan Roy's Location
Huntington Beach, California, United States, United States
Jordan Roy's Contact Details
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About Jordan Roy
Experienced Medical Device Engineer with specializing in design and development of minimally invasive cardiovascular devices including heart valves, stents and delivery catheters.
Jordan Roy's Current Company Details
Director of Clinical Affairs at Renata Medical
Jordan Roy Work Experience Details
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Director Of Clinical AffairsRenata Medical Apr 2021 - Jul 2024Newport Beach, Ca, UsResponsible for developing and overseeing clinical and regulatory activities related to the Renata Minima Stent: a class III cardiovascular implant and corresponding delivery catheter which is indicated to treat branch pulmonary artery stenosis and Aortic coarctation in neonates, babies and young children. Unlike current off-label options, the system is designed for low profile catheterization with the capability of reaching adult diameters (as shown in benchtop and animal testing).Clinical Development Activities:-Developed* and released the clinical protocols and reports used in support of Renata's IDE and PMA submission activities, ensuring all primary endpoints were measurable and had accept/reject requirements which aligned with current standard of care. -Developed* and released the Instructions for Use and initial training documentations used for EFS and Pivotal trial onboarding of physicians. Working to update training and IFU documentation based on trial learnings and physician feedback in preparation for the PMA submission of the Renata Minima Stent.*Leveraging continuous insight from consulting interventional cardiologistsClinical Oversight Activities:-Reviewed, adjusted, and approved contracting agreements with hospitals related to initial implant and follow up activities related to the implant of the study device. -Provide guidance on database updates and ongoing reporting metrics for monitoring the safety and effectiveness of the Minima Stent and any additional claims that require substantiation from cross-functional teams. -Provided initial Site Initiation training for EFS and Pivotal trial sites and continue to supporting ongoing training updates as needed. Regulatory Activities: -Perform ongoing regulatory submissions for small submission activities: Breakthrough Device Designation / 5-day notice / presub requests.-Oversee CRO for large submission activities. Related submissions: IDE / PMA submission activities -
Senior Production Quality EngineerBolder Surgical Aug 2020 - Feb 2021Louisville, Colorado, Us -
Quality EngineerSyncroness Jun 2019 - Dec 2020Create test plans for verification and validation strategy and develop/release corresponding protocol and reports for various design verification and validation activities.Performed Test Method Validations (TMV)/Measurement System Analysis (MSA) for various equipment using gage R&Rs for variable measurements and attribute agreement analysis for attribute measurements. Created test method validation best practices procedure for both attribute and variable test methods.Perform data analysis, using Minitab, for various tests including: T-tests, ANOVA, capability studies, normality assessments, mean time to failure.
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Supplier Quality EngineerTerumo Bct May 2018 - Jun 2019Lakewood, Colorado, UsPerformed supplier audits using ISO 13485:2016. Coordinated fabricated new molds on warn/missing molds for plastic and silicone parts.-Increased quality of parts while reducing the cost, due to updated mold technology.Developed test methods for new component inspections and validated them prior to release. -
Senior Quality EngineerEdwards Lifesciences Aug 2017 - May 2018Irvine, Ca, UsNew product development design control Quality Engineer: -Lead creation of design requirements document and accompanying risk management documents for a class III medical device which has been successfully implanted in human in the US. -Aided in simulated use testing and component inspection development/validation.-Performed root cause investigation on test failures and worked cohesively with cross-functional resources to implement design fixes. -
Quality Engineer IiEdwards Lifesciences Mar 2015 - Aug 2017Irvine, Ca, UsLine Support Quality Engineer:-Oversaw builds as a sustaining quality eng. during design verification and clinical builds for valve assembly, tissue treatment and packaging.-Implemented process improvements to prevent repeated non-conformances.-Performed continuous improvement to procedures by gathering comments from supervisors and implementing changes where needed.
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Quality Enineer IEdwards Lifesciences Feb 2013 - Mar 2015Irvine, Ca, UsProduct return evaluation Quality Engineer:-Performed root cause investigation on returned devices. Performed device testing toassess whether the alleged malfunction could be reproduced as well as whether the device met design specifications; Implemented corrective and preventative actions to reduce future complaint occurrence rates while ensuring patient safety.-Utilized technical writing skills to document device investigation; creating a concise and easy to follow walk through of data gathered and conclusions made concerning the returned device.
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Quality Co-OpEdwards Lifesciences Oct 2012 - Feb 2013Irvine, Ca, Us-Investigated NCRs (non-conformance reports) on received parts. Implemented reworksolutions and product disposition procedures. Identified and eliminated root cause toprevent reoccurrence.-Created routing instructions for parts being transferred to the Draper facilityfrom Irvine.-Executed and developed PQ (performance qualification) documents including anultrasonic cleaning in order to allow for in-house cleaning of purchased parts.-Developed IQ/OQ (installation and operational qualification) documents for opticalmeasuring equipment.
Jordan Roy Skills
Medical Devices
Biomedical Engineering
Capa
Design Control
Fda
Design Of Experiments
Validation
Quality System
Labview
Minitab
Verification And Validation
Product Development
Test Method Validation
Root Cause Analysis
Failure Mode And Effects Analysis
Design Requirements Document
Iso 13485
Solidworks
Standard Operating Procedure
Supplier Quality
Risk Management
Class Iii Medical Devices
Iso13485
Test Method Developement
Design Verification Testing
Design Validation Testing
Regulatory Requirements
Regulatory Submissions
Life Sciences
Continuous Improvement
Engineering
Testing
Iso 14971
Quality Assurance
Manufacturing
Development Design
Jordan Roy Education Details
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University Of UtahBiomedical Engineering
Frequently Asked Questions about Jordan Roy
What is Jordan Roy's role at the current company?
Jordan Roy's current role is Director of Clinical Affairs at Renata Medical.
What is Jordan Roy's email address?
Jordan Roy's email address is jo****@****rds.com
What is Jordan Roy's direct phone number?
Jordan Roy's direct phone number is +180155*****
What schools did Jordan Roy attend?
Jordan Roy attended University Of Utah.
What are some of Jordan Roy's interests?
Jordan Roy has interest in Science And Technology, Health.
What skills is Jordan Roy known for?
Jordan Roy has skills like Medical Devices, Biomedical Engineering, Capa, Design Control, Fda, Design Of Experiments, Validation, Quality System, Labview, Minitab, Verification And Validation, Product Development.
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