Shane Moynihan, Phd Email and Phone Number
Shane Moynihan, Phd work email
- Valid
Shane Moynihan, Phd personal email
- Valid
Solutions-driven leader with a passion for innovation in system engineering, design quality, risk management, and product ownership.Proven track record in developing and implementing lean and effective design control processes.Expertise in medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 62304, ISO 14971, IEC62366, ISO 9001, EU In Vitro Diagnostics Directive (IVDR), and Medical Device Directive (MDR).Deep cross-disciplinary capability in product ownership, requirements management, agile software development, and electro-mechanical systems.Skilled problem solver with a proven track record in building and managing teams.PMP-certified project manager with experience in defining and monitoring key metrics.Expertise in risk management, including usability and cybersecurity.
-
Senior Manager - Software DevelopmentNavi GroupDublin, Ie -
Systems Engineering ConsultantMallinckrodt Pharmaceuticals Mar 2024 - PresentDublin, County Dublin, Ireland -
Director - Medical Device DevelopmentTelperion Dec 2023 - PresentDublin, County Dublin, Ireland -
Senior Manager / Senior Staff, Systems EngineeringBrightinsight May 2021 - Feb 2024United KingdomElicitated user needs for cloud-based and mobile application medical device and clinical decision support software.Led definition of requirements, interpreting and balancing customer, business, and compliance needs.Authored and owned risk management files, including usability, cybersecurity, and privacy.Designed complex, multilayer software systems.Led projects to remediate and resolve software defects.Led strategy and definition for system verification and validation.SME on use of Jira and Atlassian toolset for agile development of regulated software.Improved processes and workpractices, authoring and delivering risk and defect management training. -
Software Design Quality Assurance ManagerWaters Corporation Apr 2018 - Apr 2021Wilmslow, England, United KingdomLed and mentored global design quality team.Owned and improved software development processes used by 400+ engineers worldwide.Supported transition of software products to modern and harmonised processes and toolsets.Conducted international training and represented company in compliance and customer audits.Led resolution of CAPAs and customer escalations.Software process SME for regulatory and cybersecurity initiatives.Developed and maintained software quality metrics. -
Product Design Compliance SpecialistWaters Corporation Feb 2016 - Mar 2018Wilmslow, England, United KingdomLed risk management for IVD software, including risk assessments, remediation activities, and training.Developed and owned software risk control requirements and traceability.Led root cause analysis and remediation activities for software.Risk management steering committee member and founder of risk management improvement workgroup. Re-designed global project risk management process and workpractices.
-
Medical Device Development ConsultantSelf Employed Jan 2015 - Jan 2016Dublin, IrelandDeveloped and managed project and quality documentation.Led technical demonstrations and trials, including statistical analysis and presentation of results.Consulted on software development and technical patent applications. -
Head Of EngineeringBiosensia May 2012 - Dec 2014Dublin, IrelandSuccessfully managed and integrated deliveries of multiple global companies, suppliers, SMEs, and consultants.Built and led multi-disciplinary engineering teams.Developed and implemented engineering processes and documentation, leading to ISO13485 accreditation.Developed new medical diagnostic devices.Oversaw system verification and validation (hardware and software).Developed technical files towards 510(k) and CE mark approvals.Managed intellectual property (IP) portfolio.Represented company at industry events and conferences. -
Senior Design EngineerBiosensia May 2009 - May 2012Dublin, IrelandLed research and development of in-vitro diagnostics immunoassay platform.Managed technical employees and projects.Invented innovations in calibration standards, fluidic devices, and optical reader systems.Designed, documented, and programmed system algorithms.Wrote and edited three patent families.Presented to international conferences, investors, and medical diagnostics multinationals.Researched and prepared critical commercial information and conducted statistical analysis.
-
Phd Research CandidateTyndall National Institute 2001 - 2007Cork, IrelandLed research on the development of next-generation optical devices and manufacturing techniques.Synthesized and characterized functional polymer micro- and nano-structures.Designed and manufactured new and unique optical devices.Conducted in-depth material science analysis.Authored and published scientific papers in high impact factor international journals.Collaborated with international academic and industry project partners. -
Test EngineerDell Apr 2000 - Sep 2000Limerick, IrelandProgrammed automated system for the compilation and archive of computer system “burn-in” test results.Designed and programmed new system for automatic statistical analysis of all “burn-in” computer failures at the Europe, Middle East, and Africa (EMEA) manufacture facility.Conducted risk analysis for the upgrading of manufacturing test protocols.
Shane Moynihan, Phd Skills
Shane Moynihan, Phd Education Details
-
Tyndall National InstituteNanotechnology: Nano-Optics, Polymer Photonics, Materials Science, Electronics -
1St Class Honours
Frequently Asked Questions about Shane Moynihan, Phd
What company does Shane Moynihan, Phd work for?
Shane Moynihan, Phd works for Navi Group
What is Shane Moynihan, Phd's role at the current company?
Shane Moynihan, Phd's current role is Senior Manager - software development.
What is Shane Moynihan, Phd's email address?
Shane Moynihan, Phd's email address is sh****@****ers.com
What schools did Shane Moynihan, Phd attend?
Shane Moynihan, Phd attended Tyndall National Institute, University College Cork.
What are some of Shane Moynihan, Phd's interests?
Shane Moynihan, Phd has interest in Guitar, Rock Climbing, Scuba Diving, 3 D Design And Printing, Travel, History.
What skills is Shane Moynihan, Phd known for?
Shane Moynihan, Phd has skills like R&d, Nanotechnology, Testing, Medical Devices, Characterization, Engineering, Materials Science, Project Management, Sensors, Semiconductors, Research, Spectroscopy.
Who are Shane Moynihan, Phd's colleagues?
Shane Moynihan, Phd's colleagues are Martin O Hart, Sean Byrne, Sarah Leadbetter, Célio Lara Júnior, Anastasiia Hordiichuk, Nailia Garifullina, Clodagh Maguire.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial