Gavin Reynolds
BioInnovate Fellow at BioInnovate Ireland- Claim this Profile
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Bio
Credentials
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Neurovascular Anatomy Course - Lecture & Cadaver Sessions
National University of Ireland, GalwayApr, 2022- Sep, 2024 -
The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements
AAMIFeb, 2020- Sep, 2024 -
Project Management Professional (PMP)
VelopiJul, 2019- Sep, 2024 -
Front End Innovation Workshop
The Moon on a StickJan, 2019- Sep, 2024 -
Medical Device Usability
BERGONov, 2018- Sep, 2024 -
Lean Product Development Training
IRDG Innovation NetworkMay, 2018- Sep, 2024 -
Advanced Microsoft Project
VelopiFeb, 2018- Sep, 2024 -
Solidworks Essentials Training
Solid Solutions IrelandAug, 2017- Sep, 2024 -
Intraosseous Cadaver Programme: A clinical skills and education programme exploring the Intraosseous space for vascular access.
Royal College of AnaesthetistsJun, 2016- Sep, 2024 -
Development Cell Efficiency Improvement Kaizen
VistaMedNov, 2015- Sep, 2024 -
Plastics Materials & processing for Medical Device Course
IbecApr, 2015- Sep, 2024 -
Customer MDI Kaizen Event
VistaMedJun, 2014- Sep, 2024 -
Lean Systems White Belt
VistaMedMay, 2014- Sep, 2024 -
Parpicipated in a 3P Kaizen Event - Achieve Customer Demand
VistaMedMay, 2014- Sep, 2024 -
CrossFit Level 1 Training Course
CrossFit, LLCJan, 2022- Sep, 2024 -
Project Management Professional (PMP)®
Project Management InstituteDec, 2020- Sep, 2024
Experience
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BioInnovate Ireland
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Ireland
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Medical Equipment Manufacturing
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1 - 100 Employee
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BioInnovate Fellow
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Aug 2022 - Present
BioInnovate, with its inception in 2011, has become recognised as a global centre for medical technology innovation. Based in one of the world’s largest medical device hubs (Galway, Ireland), BioInnovate is ideally located to enable the most forward thinking (progressive) professionals from a network of academic, clinical and industry settings to collaborate and enhance the future of healthcare and ultimately improve millions of patients’ lives worldwide.Affiliated with Stanford University’s globally renowned BioDesign program, BioInnovate encompasses the proven Needs Led Innovation approach (process) to create novel healthcare solutions to previously unmet, under-met and unrecognised problems. With a vast network of industry and clinical partners, BioInnovate has a proven track record in developing (cultivating) the newest breed of global entrepreneurs, medtech experts and healthcare leaders. The 10-month fellowship program has been honed over many years to ensure fellows and industry partners have the greatest chance of creating meaningful, impactful solutions to future healthcare needs.
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CrannMed
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Ireland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Senior Research And Development Engineer - Neurovascular
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Sep 2021 - Aug 2022
• Senior Engineer will be the technical lead responsible for design and development of catheters used for the delivery of embolic particles and implants within the peripheral and neurovascular anatomy.From first principles, develop concepts and prototypes, should have a strong knowledge of materials, processes and technologies used for catheter manufacture.• Engage with KOLs to ensure product specifications and requirements meet end user needs.• Coordination of In-vitro testing and animal studies with KOLs.• Create innovative solutions and continuously look to improve our delivery systems.• Ensure R&D lab and test area and equipment are following best practices and compliant to ISO13485.• Create and set up bench tests for the evaluation of device performance and simulated use.• Generate product specifications, design verification protocols and associated test plans.• Working with Design Assurance team ensure all design activities associated with regulatory submissions are up to date and complete.• Ensure project timelines are met, manage vendors used for prototype builds. Put in place actions to mitigate risks.• Communicate and update project activities using project management methodologies.• Lead the establishment and set up of pilot lines used to build early batches of pre-clinical devices.• Manage one to two junior engineers and technicians. Manage their day-to-day activity.
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Teleflex Incorporated
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Netherlands
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Mining
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1 - 100 Employee
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Senior Research And Development Engineer - Urology & Tracheostomy
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Mar 2020 - Sep 2021
• Individually lead the Design and Development process for both new and transfer products in compliance to internal procedures including EU and FDA requirements from Development phase up to Transfer to Production. • Gathering clinical/user needs and translation into technical specifications.• Component/assembly design and preparation of associated drawings and specifications.• Prototype design, building and testing.• Test method development; identification and procurement of equipment for inspection and test, test method validation and training.• Generation, analysis and interpretation of test data.• Developing and delivering project plans to performance, time and cost targets.• Liaising with external resources to achieve project goals.• Implement the risk management process and aid with the preparation of risk management files including Use and Design FMEAs as required in accordance with company procedures and EN ISO 14971.• Identify product testing required, create design verification and validation plans, protocols and reports including specifically advising on sample sizing; Stability and Transportation testing• Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records in conjunction with Design Assurance.• Generation and/or review of technical documentation / change requests to related to design activities.
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Research and Development Engineer - Vascular, Urology & Tracheostomy
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Mar 2016 - Mar 2020
• Individually lead the delivery of projects to maintain business continuity in areas such as 1) complying with regulations; 2) resolving product performance issues; 3) sustaining supply chain continuity; and 4) improving margins.• Work related to products and components may include efforts in all technical phases of product and process development, including design and development planning, requirements definition, product development, root cause analysis, verification/validation and manufacturing aspects. Aid in product improvement and cost reduction, facilitate change management and documentation, develop, troubleshoot and maintain manufacturing processes, equipment and systems.Work related to compliance issues may include research of existing procedures and documentation as well as writing or revising standard operating procedures and other documentation.• Directly lead engineering efforts to develop components, specifications and processes with input from technical experts, physicians, marketing and manufacturing adhering to the design control process. Lead projects in the redesign or replacement of existing components/assemblies and processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner. Interface with suppliers, Strategic Sourcing, R&D, Quality and Regulatory Affairs to deliver projects. • Perform product testing, create models and prototypes to prove out new designs and changes to existing designs.• Lead and participate in design and technical phase reviews.• Support regulatory submissions and clinical trials as required.• Ensure projects are developed and documented compliant with the Quality System.• Successful Remediation of multiple Design History Files for FDA Audit Review.• Attended multiple Cadaver Labs & Medical Conferences.• Participated in multiple Formative studies to gain usability information.
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VistaMed
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Ireland
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Medical Equipment Manufacturing
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100 - 200 Employee
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Process Engineer
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Feb 2014 - Mar 2016
Job Description:• Leading Projects and Project teams to ensure Project Goals are met especially on time delivery, quality requirements and cost targets are achieved.• Planning, implementing and co-ordination of New Product Introductions to include: product design, product specifications, process validations identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement in accordance with VistaMed Procedures and Regulatory standards.• Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of new and existing production. • Coordinating the supply of extrusions, if required, with the Extrusion department including agreeing specifications of tubing, resins and quality requirements.• Ensuring effective and comprehensive customer communication throughout the duration of the project.• Planning and co-ordination to ensure that the necessary testing, evaluation & control of equipment measures are in place to monitor & support product quality in accordance with VistaMed Procedures and Regulatory standards.• Planning and coordinating New Product Design to include Design Inputs, Design Outputs, Design Verification and Design Validation including, where necessary, Clinical trials, Technical Files, Technical Reports and Design history Files in accordance with VistaMed procedures and Regulatory Standards.• Development of Manufacturing Process in conjunction with New Product Introduction Team including, as required, training of technicians, process operators and other staff.• Planning and implementing manufacturing cell lay-outs, work station design and material handling to ensure efficient manufacturing to meet product cost targets, efficiency targets and quality targets.• Leading Project management teams to ensure on-time task completion, effective team work, good motivation and effective communication.
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Siemens Healthcare
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Italy
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Medical Device
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1 - 100 Employee
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Test Technician
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Oct 2013 - Feb 2014
Job Description:•Performing inspection operations on sub-assemblies, modules and systems using engineering drawings, schematics, flow diagrams, specifications and methodologies;•Preparing samples, reagents and diluents for chemical testing of systems and modules;•Establishing causes of malfunction and non-conformance in the mechanical, electrical, hydraulic and chemical operation of systems with a minimum loss of test time;•Assisting Engineering in the initial validation, installation and verification of new test procedures, equipment and products;•Assisting Engineering in the design of test fixtures and modules inspection/test procedures;•Completing and maintaining all necessary paperwork, test data etc. for each system/module to ensure that accurate Quality records are available;•Overseeing and checking any repair work that has to be carried out to ensure that the fault is corrected;•Working with Quality procedures, relating to material flow, material handling, processing of defective material, acceptance and rejection procedures, ECN monitoring, concessions etc.•Awareness of the risks involved i.e. in handling dangerous corrosive or infectious materials and ensuring that all safety rules and procedures are observed;•Training in new personnel or existing Technicians on unfamiliar systems or modules;•Supporting production ramps to deliver customer product on time and to the required quality level.
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General Monitors
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United States
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Appliances, Electrical, and Electronics Manufacturing
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1 - 100 Employee
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Technical Support Technician
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Jan 2009 - Sep 2012
Job Description:Fully responsible for the provision of technician support to a highly automated assembly line.Ensured downtime was minimised and assisted with trouble shooting and fault finding.Responsible for testing products ensuring they met high quality standards and adhered to specification. Developed an excellent knowledge of the products BOMs and schematic drawings.Ensured the production plan was adhered to.Carried out planned and unplanned maintenance on equipment.Key member of a team involved in a number of successful process improvement projects. Ensured Health and Safety procedures were adhered to and worked as the fist aid responder in the area.
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Boston Scientific
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Product Builder
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May 2008 - Jan 2009
Job Description:Fully responsible for the assembly of medical devices in a GMP and FDA environment.Performed inspections and quality checks ensuring the Catheters met very high quality standards.Ensured GMP procedures were adhered to at all times.Adapted work schedule to ensure predetermined production targets were met.Full responsibility for the accurate maintenance of production and quality records.Worked closely with colleagues to ensure consistency of work across shifts.
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PENN ENGINEERING SERVICES LIMITED
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United Kingdom
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Industrial Machinery Manufacturing
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1 - 100 Employee
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Technical Operator
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Sep 2006 - May 2008
Job Description:Key member of a team responsible for the manufacture of product in a high volume environment.Maintained a high focus on quality at all times, working to very tight tolerances.Conducted regular maintenance checks on equipment and carried out repairs as necessary.Performed regular quality checks, dispositioned product and highlighted any recurring issues.Fully responsible for carrying out machine changeovers.Ensured the production plan was adhered to and carried out trouble shooting when required.Ensured all production documentation was accurately completed.
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Education
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2022 - 2023
National University of Ireland, Galway
BioInnovation, Science & Engineering -
2012 - 2013
Institute of Technology, Sligo
Honours Degree, Mechatronics, Robotics, and Automation Engineering -
2010 - 2012
Institute of Technology, Sligo
Bachelor of Engineering in Mechatronics Engineering, Engineering -
2002 - 2004
Institute of Technology, Sligo
Certificate in Engineering in Mechanical Engineering, Engineering
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