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Chief Operating Officer
hace 3 meses
Chief Operating Officer:
The COO is responsible for the overall management of the Company's' Research and Development, Manufacturing and Product Logistics and Operations activities requiring a balance of leadership ability as well as technical skills.
The individual will be responsible for leading the development of our clients novel ablation system, assessing, aligning and Managing all ongoing R&D and Manufacturing activities, and structuring the R&D and Manufacturing organization for the Company as it enters Design For Manufacturing (DFM) of the single use disposable component and their console/capital equipment, before entering the formal regulatory clinical arena.
Responsibilities:
Act as key point of contact for all R&D, Manufacturing and Logistics activities and will direct the ongoing engineering initiatives to produce unique design solutions.Fosters a team approach to R&D/Development and Manufacturing activities while providing a mentoring environment to encourage the growth of the staff.Work cooperatively with Preclinical and Clinical, Quality, Regulatory, and Management to ensure process and logistics issues are effectively resolved in a timely manner.Lead cross-functional team meetings to prioritize, plan, schedule and execute product development, project improvements, focusing on risk mitigation, timelines and costs.Drive process validation and scale-up activities.Oversee troubleshooting on products/process problems as related to design, material, or process. Manage root cause investigation and help drive CAPA resolutions.Oversee the fabrication of manufacturing tools and fixtures to support production, quality, and engineering processes.Manage assembly and production of DOC Controlled engineering, pre-clinical, clinical builds for on-time delivery of high-quality products.Ensure production personnel are fully trained on all manufacturing, test and inspection procedures.Qualifications:Proven Medical Device experience, growing to a managerial/leadership positions within R&D, Manufacturing and logistics.Class II and III Capital Equipment with Software and Single Use Class III Disposable Medical Device experience. Experience in the field of Electrophysiology, Interventional cardiology, Endovascular therapies and imaging essential, Optical Coherence Tomography (OCT) is a plus.Single Use Disposable Device Development and Manufacturing experience with products incorporating optical lenses, optical fibers, micro assembly and use of various epoxies, adhesives, laser welding, and fixture development etc is beneficial. Capital Equipment Development and Manufacturing experience with products incorporating optics, electronics, software and user interface. Extensive experience with a track record of successes from product conception through to strategic exit/commercialization and production of Class II and Class III products.