
Rob Neary
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About me
Validation Specialist at UA Manufacturing
Education

Calasanctius College, Oranmore
2004 - 2009Leaving Certificate 2009
Dublin Institute of Technology
2016 - 2017Bachelor's degree Medical Device Innovation Second Class HonoursModule Listing:Anatomy & PhysiologyBasic Principles of Medical Device TechnologyComputer-Aided Design & Solidworks 2D/3D ModellingApplied BiomaterialsProject Management & InnovationTeam Design ProjectMedical Device Design & AnalysisMedical Device ManufacturingValidation & Regulatory AffairsCAD & Analysis (Solidworks, Part, Assembly, Mould Design & Finite Element Analysis (FEA))Lean Six Sigma (Green Belt)Team Design Project

Galway-Mayo Institute of Technology
2013 - 2014Certificate (Special Purpose Award) in Science in Medical Device Technology DistinctionModule Listing:• Industrial project.• Learning to Learn.• Medical Device Technology.• Current Industrial Concepts.• Work Placement/Project.• Quality Auditing.

Athlone Institute of Technology
2009 - 2012Mechanical EngineeringIn my Final Year Project, I designed and manufactured a Single Valve Cylinder Head & A Single Cylinder Oscillating Engine with the use of CAD/CAM and Solid Works for the drawing and solid modelling of the assembly. Each part was then manufactured to its specifications within tolerances using CAD part and assembly drawings. I used a Metal Lathe and a CNC Milling Machine along with other common practical tools and measuring equipment.Modules included:• Materials• Energy… Show more In my Final Year Project, I designed and manufactured a Single Valve Cylinder Head & A Single Cylinder Oscillating Engine with the use of CAD/CAM and Solid Works for the drawing and solid modelling of the assembly. Each part was then manufactured to its specifications within tolerances using CAD part and assembly drawings. I used a Metal Lathe and a CNC Milling Machine along with other common practical tools and measuring equipment.Modules included:• Materials• Energy Systems• Thermofluids• Mathematics • Mechanics• Control & Power Technology• CAD 2D/3D, Solid Works• Energy & Sustainability• Combined Heat & Power• Operations Management• Instrumentation• Machine Operations (Lathe, Milling, CNC)• Communications Show less

Dundalk Institute of Technology
2022 - 2024Master of Science - MS Computing in Games & Extended Reality First Class HonoursModule Listing:Year 1:- Software Engineering- Extended Reality Theory- Advanced 3D Animation and Game Engine Pipeline- Data Analytics for Immersive Environments- Narrative Design and Scene Composition- User Experience DesignYear 2:- Research Skills for Product Development- Sound Design for Immersive Environments- Rich Media Product Production - Research Thesis
Experience

Supermac's
Jul 2010 - Oct 2012Service Staff• Responsible for fast and efficient service to customers.• Working well in a team under pressure in a fast paced environment.• Multitasking.• To provide ongoing support to the management team to ensure Supermac’s customers receive the best quality, service and cleanliness every time.• Flexibility to work in all areas of the restaurant as requested by the manager.

Rentokil Pest Control
Oct 2012 - Feb 2013Service Technician
Boston Scientific
Feb 2014 - Jul 2014R&D Technician•Assist in the research, design and acquisition of new fixtures, equipment and prototyping capabilities.•Verification of raw data compared to design compliance data sheets and results in Minitab.•Review data from tests completed in the Design Assurance Lab.•Assist and carry out feasibility and DV tests on defects.•Interact with external extrusions vendors, sampling different types of polymer tubing & balloon prototypes such as multi-lumen extrusions, PTA & Catheter hub moulds and complete assemblies. Show less

Medtronic
Jul 2014 - Dec 2015Manufacturing Engineering Technician (SAP ME)• Responsible for testing the installation, operation and performance of manufacturing support software SWAT, (Spray Weigh Automation Technology)• Assisted with development and execution of SWAT software validation and all supporting validation documentation e.g. SRS, TRM, IQ, OQ & PQ Protocols and associated Reports• Writing script protocols for Functional User Testing and User Acceptance Testing in SAP MES (Manufacturing Execution Systems) and Quality Center• Consistent compliance with product quality standards• Consistent attention to detail to ensure accurate, high quality products• Provide technical support to direct manufacturing during SAP MES rollout phase• Troubleshooting and technical support of process, materials and equipment operation• Responsible for the preparation, maintenance and control of appropriate documentation outlining product processing work steps• I.T. and engineering support Show less

Thermo King
Sept 2017 - Nov 2017Production Operator
Merit Medical Systems, Inc.
Dec 2017 - Apr 2018Production OperatorHemostasis Valves

Medtronic
Apr 2018 - nowProject Oval - transfer all commercial manufacturing activities from Brescia, Italy to Galway, Ireland.Technical Expert for all Peripheral Vascular Balloon Forming/Manufacturing at Medtronic, Galway• Process development/validations• Continuous Improvement/ improve manufacturing process using engineering methods (A3, lab book studies, statistical analysis)• Establish project plans to ensure deliverables are met• Analyze and resolve basic manufacturing and compliance issues (NCMR, CAPA, audit observations)• Develop basic experiments and tests to qualify and validate manufacturing processes; analyze results; make recommendations; and develop reports• Provide necessary engineering support to commercial operations ensuring availability of all equipment and tooling, and removing constraints to reduce overall downtime• Liaise with external vendors to purchase new/upgrade existing equipment and software Show less • Balloon Manufacturing Engineering Technician with a diverse knowledge of polymers and balloon forming techniques• Coronary Balloon Forming, Stent Delivery Systems (SDS) and Balloon Angioplasty sub-assemblies• Performing changeovers of product family/sizes, machine parameter adjustments, extrusion batch changes for optimised setups ensuring all critical parameters are within tolerance and specification and general troubleshooting in process• Peripheral Balloons - Kyphon Inflatable Bone Tamp (IBT) Balloon forming (used to treat pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions) - general troubleshooting and preventative maintenance of the IBT Balloon machines• Continuously working to improve efficiency by regularly carrying out cycle time measurements of the process, investigating any cycle time deviations and coordinating with cross-functional teams to implement solutions• Calibration of machines critical components used in balloon forming and measurements• Creating and executing Engineering Build Requests (EBR) for Glass & Metal Mould Qualifications and Compliance Testing Builds (OQ, PQ)• Completing the Non-Conformance Material Report (NCMR) and relevant memorandum each month for balloon tubing deemed unsuitable for balloon forming• Participating in cross functional teams and continuous improvement projects (A3)• Technical Lead - Project Oval Transfer (Brescia, Italy - Galway, Ireland) Show less
Manufacturing Engineer II
Jul 2021 - nowManufacturing Engineer I
Dec 2019 - Jun 2021Manufacturing Engineering Technician
Apr 2018 - Dec 2019

Point Force Group
Jul 2024 - Aug 2024General Construction Labourer
EWS Recruitment
Aug 2024 - Oct 2024General Construction Labourer
UA MANUFACTURING
Oct 2024 - nowValidation Specialist
Licenses & Certifications

SOLIDWORKS CAD Design Associate (CSWA)
Dassault SystèmesSept 2025
General Construction Induction Card
WorkSafe VictoriaJul 2024
Computerised Systems Validation
PharmOutDec 2024
Full Australian Driving Licence
VicRoadsAug 2024.webp)
Working with Children Check
Victoria State Government (Victorian Government)Apr 2025
Full Irish Driving Licence
Road Safety AuthorityNov 2020
Internal Quality Management Systems Auditor
International Register of Certificated AuditorsJan 2014
Languages
- spSpanish
- enEnglish
- irIrish
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