Brian Ledwith Email and Phone Number
R&D Director progressing from an experienced Senior Product Development Engineer and Engineering lead roles with a 16 year demonstrated history of successful product development launches in the medical device industry. Skilled in Medical Device product development, Team Management, Risk Management aligning to ISO 13485/FDA CFR 820 regulations. Strong Mechatronic engineering professional graduated from Dublin City University.
Aveta Medical
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Chief Executive OfficerAveta Medical Oct 2023 - Present -
R&D DirectorAveta Medical Aug 2022 - Oct 2023 -
R&D Product Development ManagerTe Connectivity Nov 2019 - Aug 2022Galway, Ie -
Product Development ManagerSynecco Jun 2018 - Nov 2019Whitegate, Co.Clare, IeManage the product development team Overseeing project performance against approved contractsMaking key decisions to keep projects on track and aligned with customer and regulatory requirementsManaging resources for the department to ensure efficient execution of projects Developing new capabilities within the department to broaden the business offering. -
Product Design Engineering LeadSynecco Apr 2017 - Jun 2018Whitegate, Co.Clare, IeLeading the Engineering team to deliver client medical device projects from inception to product release. Progressing the team to learn new capabilities in the following areas:1. Rapid prototyping in house to speed up the design thinking process - learning fast and cheaply2. Progress learning on additive manufacturing to enhance product design 3. Capturing Customer requirements and tracking design iterations and decisions using QFD's to link back to the defined customer requirements4. Linking customer requirements to competitor products performance table to establish the project goals for the product.5. Designing through first principles and free body diagrams to understand the interactions. -
Senior Product Development EngineerSynecco Jun 2014 - Apr 2017Whitegate, Co.Clare, IeDelivery of customer projects from inception to product release. This incorporated medical devices to consumer products. Manage Client projects, utilizing ISO 13485 compliant documentation and stage gated project management. -
Senior Mechanical Design EngineerBio-Medical Research Limited Jan 2010 - May 2014Galway, Galway, IeMechanical design and testing of Medical devices to IEC 60601 3rd edition standardManage Design Control to 21 CFR 820 and in compliance to ISO 13485Design high end consumer medical devices and have worked in association with Philip Treacy on the Philip Treacy Face ProductLiaising with Chinese manufacturing sites. Traveling to China to work with suppliers to reduce time to market, from initial concept to final design. Ensuring quality for Functionality and Aesthetic. Working to maximise efficiency for high volume products.Aesthetic design incorporating;In Mould DecorationHot StampingLaser etchingVacuum PlatingEDPMeeting Suppliers for new process to exceed customer requirements -
R&D EngineerCovidien Mar 2007 - Dec 2009Design and Development of Adult and Paediatric endo tracheal tubes.Liase with the Key Opinion Leaders such as Dr Markus Weiss to development market leading endo and trach paediatric and adult tubesVisited Ghent University Hospital Belgium and other leading Paediatric hospitals around Europe to gain key design insights and feedback on current designs. Obtained 5 IP's on new design concepts during this position.Developing innovative designs to meet customer requirements while ensuring no infringements on competitors intellectual property
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Process Development EngineerBoston Scientific Jan 2005 - Feb 2007Marlborough, Ma, UsTransfer of the New projects from R&D to routine production.Installation and qualifying the assembly lines Managing equipment buildDeveloping the assembly and measuring proceduresTraining operators on assembly and measurement proceduresCompleting test method validationsValidation of assembly processCompleting Machine software validationsCompleting component build validations IQ OQ PQ PPQProcess variation reduction using DMAIC six sigma yellow, green and black belt methods.
Brian Ledwith Education Details
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Dublin City UniversityAutomation Engineering
Frequently Asked Questions about Brian Ledwith
What company does Brian Ledwith work for?
Brian Ledwith works for Aveta Medical
What is Brian Ledwith's role at the current company?
Brian Ledwith's current role is CEO/Director of AVeta Medical - non hormonal medical devices for the treatment of menopause GSM VA.
What schools did Brian Ledwith attend?
Brian Ledwith attended Dublin City University.
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