Siobhain Lowe
Sr Director, Engineering Programs @Gaumard Scientific
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WORK HISTORY
Sr Director, Engineering Programs @Gaumard Scientific
Miami-Fort Lauderdale, FL, US
I have been progressively promoted within the organization, retaining oversight of prior responsibilities while expanding into broader leadership roles. I assumed management of the SAP and Receiving & Inventory teams to spearhead ERP/MRP system rollout.• Oversee the SAP team responsible for implementation of the SAP Business One ERP system that interfaces with all departments and C-suite.• Develop project plans in collaboration with all department stakeholders to ensure buy-in and collaboration between teams that are impacted by new software and process implementation.• Develop and integrate SAP processes to meet stakeholders\' needs as well as develop and implement new systems for business controls.• Streamline the Receiving and Inventory processes to reduce inventory and improve efficiencies while meeting all production needs.• Rollout management modules, including inventory, production, engineering change control, MRP.Through this work, new control systems are being established for greater visibility of all business aspects by Executive Management, and improvements to efficiency are being achieved through reduction in redundancies.
EDUCATION
Florida International University
B.S, Chemical Engineering (Minor: Biomedical Engineering)
Florida International University
M.S., Biomedical Engineering
Florida International University
Ph.D., Biomedical Engineering
ABOUT SIOBHAIN LOWE
I am an engineering executive with nearly 25 years of experience driving research and development initiatives and overseeing complex projects and programs. I bring deep expertise in Process Control, Statistical Analysis and Design of Experiments. I am skilled at managing high-performing engineering and technical teams across diverse industries, and I am known for aligning teams around shared goals, improving operational efficiency and advancing innovation from concept to commercialization.EXPERIENCE OVERVIEW• 15+ years: Management of cross-functional and high-performing teams (R&D, Electrical, Mechanical, Materials, Manufacturing and Production Engineers, including Managers, Technicians and Operators) that lead complex system implementations and deliver practical, impactful solutions• 20+ years: Research and development from concept to market• Development of operational departments and groups from inception to viable entities; including hiring and mentoring of qualified personnel• Personal growth management philosophy by establishing an environment for career development• Resource planning and allocation, including budget, personnel, space and capital equipment• Design of Experiments, Process Control and Statistical Analysis• Verification and Validation Testing, including animal and human trials• Experience within an FDA-controlled, document-controlled, cGMP environment with a well-defined QMS (Quality Management System)• Design and development of Class I, Class II, Class Medical Devices and Medical Training Simulators• Production of Class II and Class Medical Devices and Medical Training Simulators• 3D CAD: Translates technical fluency in SolidWorks and advanced manufacturing methods into leadership that accelerates innovation, design efficiency and production-readiness• Documentation: Product Specifications, Drawings, Tooling, Manufacturing Instructions, Routing, Protocols, Design History Records, Reports, Receiving Inspection, Bill of Materials, Schematics, Engineering Change Notices (ECN), Product Deviation Notices (PDN), Change Requests (CRF), Process Flow• Problem and conflict resolution• Biocompatibility testing, including but not limited to in vitro testing through radiolabelling of human platelets in whole blood.• Fatigue characterization of polymeric and composite materials.• Design and prototyping of minimally invasive, percutaneous, and stented polymeric trileaflet heart valves for in vitro and in vivo verification and validation.
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