Siora Maclean
Co-Founder at AuriGen Medical- Claim this Profile
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Experience
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AuriGen Medical
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Ireland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Co-Founder
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Sep 2018 - 5 years 4 months
County Galway, Ireland Our Mission AuriGen Medical is an Irish electrophysiology and structural heart company dedicated to transforming the management of longstanding persistent atrial fibrillation by developing the first cardiac implant to treat both the stroke and arrhythmia risk associated with this devastating condition. http://aurigenmedical.com/
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Synecco
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Ireland
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Medical Equipment Manufacturing
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1 - 100 Employee
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Project Management
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Jan 2017 - Aug 2018
County Galway, Ireland
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Senior Project Manager - Design Services
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Apr 2011 - Dec 2017
Galway Most recent achievement in this role; completed a co-development project (Electrophysiology application) with a major multinational medical device company culminating in commercial product launch in Q4 2013. The project life-cycle spanned just under 3 years and initiated with concept development & objective design features identified as target marketing advantages against predicate device(s). Manged the project through design development & validation culminating in regulatory submission in a… Show more Most recent achievement in this role; completed a co-development project (Electrophysiology application) with a major multinational medical device company culminating in commercial product launch in Q4 2013. The project life-cycle spanned just under 3 years and initiated with concept development & objective design features identified as target marketing advantages against predicate device(s). Manged the project through design development & validation culminating in regulatory submission in a number of target markets and in parallel worked through process development to DFM principles to complete process validation and manage the project through production ramp & product release for commercial launch. Product has completed several months of commercial use with positive feedback from users & customer and target center predicate conversion rates also positive.
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Project Manager/Senior Design Services Engineer
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Feb 2009 - Mar 2011
Galway Successfully lead a number of technical design & manufacturing projects and project teams for a variety of international customers.Areas of application included Cardiovascular, Peripheral Vascular, Structural Heart. Responsible for the co-ordination of project budgets, timelines, planning, resources and technical guidance. Effectively developed strong and positive working relationships with customers across an array of cultures and nationalities and tailored our team’s approach and response to… Show more Successfully lead a number of technical design & manufacturing projects and project teams for a variety of international customers.Areas of application included Cardiovascular, Peripheral Vascular, Structural Heart. Responsible for the co-ordination of project budgets, timelines, planning, resources and technical guidance. Effectively developed strong and positive working relationships with customers across an array of cultures and nationalities and tailored our team’s approach and response to match and exceed customer expectations in the delivery of project completion within the target budget and timeframe.
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Project Manager - R&D
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Apr 2008 - Oct 2009
Galway & Temecula CA, USA Successfully managed a next generation Endovascular NPI project through the key milestone stages of Design Verification, Design & Process Validation to FDA & CE approval and first commercial builds. Developed & maintained project charters and worked with cross-functional project teams to manage project risk & mitigation, key milestones & budget. Also managed site-to-site communications for this project.
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Senior R&D Engineer
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Aug 2006 - Apr 2008
Galway Technical lead for several R&D projects, completed product and process development & process validation of current and next generation Endovascular products. I designed and tested prototypes, developed & validated test methods, drove device risk management as per ISO14971. Responsible for design verification & validation test report compilation in accordance with internal design-control and ISO13485 requirements. Supported 510K & CE submissions and worked to implement design for manufacture… Show more Technical lead for several R&D projects, completed product and process development & process validation of current and next generation Endovascular products. I designed and tested prototypes, developed & validated test methods, drove device risk management as per ISO14971. Responsible for design verification & validation test report compilation in accordance with internal design-control and ISO13485 requirements. Supported 510K & CE submissions and worked to implement design for manufacture principles early in the process development stages. Team developed manufacturing processes from R&D stage to transfer to production and launch readiness stages including process validation and volume ramp-up accordance with Quality & Regulatory requirements.
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R&D Engineer
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May 2005 - Aug 2006
Galway
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National University of Ireland, Galway
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Ireland
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Higher Education
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200 - 300 Employee
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Research Engineer
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2002 - 2005
Galway Developed the application of a novel glass fibre and thermoplastic resin system for use in the development of a wind turbine blade. Investigated mechanisms involved in the consolidation of stitched glass fibre reinforced cyclic polybutylene terephthalate (CBT™) during processing establish an optimum process window for manufacture. Process was then applied to a patented design to manufacture wind turbine blades for commercial use. Publications & Patents: • S.M.Coll, A.M. Murtagh, C.M.Ó… Show more Developed the application of a novel glass fibre and thermoplastic resin system for use in the development of a wind turbine blade. Investigated mechanisms involved in the consolidation of stitched glass fibre reinforced cyclic polybutylene terephthalate (CBT™) during processing establish an optimum process window for manufacture. Process was then applied to a patented design to manufacture wind turbine blades for commercial use. Publications & Patents: • S.M.Coll, A.M. Murtagh, C.M.Ó Brádaigh, Resin Film Infusion of Cyclic PBT Composites: A Fundamental Study, Proc. of the 25th SAMPE Europe International Jubilee Conference, Paris Expo, Paris, Porte de Versailles, 2004 • S.M.Coll, A.M. Murtagh, C.M.Ó Brádaigh, Resin Film Infusion of Cyclic PBT Composites: Consolidation Analysis, Proc. of the 7th FPCM International Conference on Flow Processes in Composite Materials, University of Delaware, Centre for Composite Materials, July 7-9th, 2004 Show less
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Mednova Ltd
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India
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Hospitals and Health Care
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1 - 100 Employee
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R&D Engineer
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2000 - 2002
Galway Integral part of a design team to develop next generation Endovascular medical devices through the stages of initial concept, prototype, bench testing, verification, validation to FDA approval. Worked through all stages of R&D prototyping to operational manufacture, including process development, compilation of manufacturing procedures, training of operatives and sourcing of raw materials.
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Education
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Queen's University Belfast
Masters, Chemical Engineering -
Queens University of Belfast
Masters Degree of Engineering, Chemical Engineering