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A performance-oriented C-level Engineering Leader with extensive expertise in Product Development. Demonstrated success in launching mission-critical products across diverse engineering domains, including IoMT, Medical Devices and Life Sciences. Known for visionary leadership, fostering a global perspective, driving innovation, and cultivating efficient processes. Proven track record in assembling, inspiring, and empowering globally dispersed product development teams Class II/III Medical Device & IVD Development Digital Health Solution Design & Development Digital Transformation and Cultural Change Investor presentations and Fund raising Product & Technology strategy Outsourced Manufacturing selection & transfer
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Executive Vice President R And DOrganoxOxford, Gb -
Chief Technology OfficerBlatchford Sep 2020 - PresentBasingstoke, Hampshire, GbRecruited at C-level as a member of the new executive team for a prominent manufacturer of advanced microprocessor driven lower limb prosthetic and orthotic devices that had recently undergone acquisition by Private Equity – a transition from 130 years of the original family ownership. Entrusted with leadership of R&D, PMO, IT and the Enterprise Digital Transformation Office • As a member of the leadership team, played a pivotal role in driving a transformative organizational and digital overhaul of the business, leading to a remarkable 300% EBIDTA growth over three years, propelled in part by a significant increase in the vitality index from low single digits to the mid-twenties.• Defined the product and technology strategy aligned with the organization's mission to deliver superior clinical outcomes using breakthrough technology• Led the doubling of R&D investment, facilitating significant investment in labs, test equipment, digital twin development and simulation-based design, all with a view to reduce new product development time to market• Formulated and guided a new R&D team to replace the legacy product portfolio with a new offering based on a common platform paired with a digital twin and an innovative digital health offering• Built and supervised the team responsible for developing a cloud-based Digital Health solution, encompassing manufacturing, service, wearer, and clinical-facing portals and apps• Launched a revolutionary digital health-enabled microprocessor-based knee ankle foot orthoses, enabling individuals with lower limb nerve damage who were previously reliant on walking aids or wheelchairs to regain independent mobility. The Digital Health solution facilitates remote clinical consultations, streamlines after-sales support, and enables over-the-air software updates.• Led the Digital Transformation Office that deployed a suite of cloud based digital solutions for ERP, PLM, CRM, eQMS and a new global website with eCommerce capability. -
Chief EngineerQuanta Dialysis Technologies Apr 2016 - Aug 2020Warwick, GbRecruited at C-level to lead Product Development & IT to commercialize SC+, an award-winning Hemodialysis system for the home and clinic use. Successfully defined, developed, and deployed the Digital Health solution to accompany the product offering• Member of the executive team that raised over £50M to enable the launch of the SC+, an innovative award-winning hemodialysis system designed to support the continuum of care from the clinic to home• Lead the team (~60) that defined and developed the commercial hardware, software, and consumable platform for the award-winning SC+. Key success factors are Usability, Industrial Design and Total Cost of Ownership• Built up a consumables design and development team capable of supporting the manufacturing scale-up of high-volume plastics disposable elements of the SC+ system• Recruited and led the Web Solutions team that defined and developed the cloud-based Digital Health solution to accompany the SC+ commercial launch. The offering supports manufacturing, service, patient, and clinical facing portals • Established a self-sustaining Project Management Office (PMO) from scratch, progressively enhancing the organization's ability to strategically plan, monitor, control, and successfully execute complex multi-year projects. This transition played a vital role in facilitating the evolution of the company's focus from development-oriented to commercially driven.• Identified and cultivated beneficial partnerships with a diverse range of external collaborators, both nearshore and offshore, to augment the in-house design team's capabilities across multiple areas, including product development, reliability, industrial design, human factors, cybersecurity, and web solutions.• Collaborated closely with the Operations team to select a global Contract Manufacturing Organization (CMO) capable of meeting the stringent requirements for manufacturing the SC+ device, ensuring high-quality production and smooth supply chain operations -
Head Of Engineering R&D And ItBiocartis May 2013 - May 2016Mechelen, Be• Part of leadership team that took Biocartis to the largest Life Sciences IPO (April 2015) on the Belgian Euronext Exchange raising €115M with a total company valuation of €465M.• Responsible for fostering the Engineering team (~35) including a growing in-house capability coupled with outside development partners. Team responsible of Technical Feasibility, Product Design & Development, V&V, Reliability testing, Life Cycle Management, Labeling and Packaging and Localizations for worldwide market expansion• Successfully launched the award winning Idylla™ platform with the first BRAF assay for the oncology pipeline. Projects to continue to build assay menu has continued with internal and external partners e.g. Johnson and Johnson. System placements continue to outstrip expectations. Idylla has consistently exhibited high reliability and performance since start of verification in the hands of customers, external collaborators including several KOLs and internal assay development teams • Continue to expand software tooling to increase productivity of assay development teams including capability to enable co-development of new assays with teams located over multiple time zones and continents• Initiated and lead project that is on target to outsource Instrumentation manufacturing to a Contract Manufacturing organization with a global footprint and proven track record in medical devices which will result in a significant reduction in COGS with further cost down opportunities over the coming years• Asked to lead IT Steering Team responsible for the selection and deployment of business applications. Reorganized the team structure, related processes and replaced outside contractor to repair and complete long delayed deployment of the ERP system. Went on to select and deploy CRM tool on time and budget to support product launch amongst others -
Head Of R&D, Molecular DiagnosticsThermo Fisher Scientific Sep 2011 - Feb 2013Waltham, Ma, Us• Invited to lead the R&D team (~35 Scientists & Engineers) for the newly formed Molecular Diagnostics division at Life Technologies charged with developing Companion Diagnostics assays to make LT a dominant player in Personalized Medicine. Responsible for qPCR Instrument -
Director, Systems Engineering & V&V - Qpcr PlatformThermo Fisher Scientific Jul 2010 - Sep 2011Waltham, Ma, Us• Hired to lead qPCR division’s Systems Engineering team (~35 Engineers split between CA and Singapore) responsible for Requirements Development, System Integration and V&V for instrument and assay development projects -
Director, Software And Electrical SystemsLuminous Medical Aug 2007 - Jul 2010Us -
Director, Electronic & Software SystemsMedtronic Jan 2005 - Jan 2007Minneapolis, Mn, Us -
Director, Software DevelopmentMedtronic Oct 2003 - Jan 2005Minneapolis, Mn, Us -
Program ManagerBiotronik May 2002 - Oct 2003Berlin, De -
Account Leader And Field ManagerCiber Inc May 1997 - Feb 2002
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Manager, Software DevelopmentMgc Diagnostics Sep 1995 - May 1997St. Paul, Mn, Us -
Software EngineerMgc Diagnostics Sep 1993 - Sep 1995St. Paul, Mn, Us
Amit B. Skills
Amit B. Education Details
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University Of MinnesotaBiomedical Engineering -
Shivaji UniversityElectrical And Electronics Engineering
Frequently Asked Questions about Amit B.
What company does Amit B. work for?
Amit B. works for Organox
What is Amit B.'s role at the current company?
Amit B.'s current role is Executive Vice President R and D.
What is Amit B.'s email address?
Amit B.'s email address is aa****@****ail.com
What schools did Amit B. attend?
Amit B. attended University Of Minnesota, Shivaji University.
What skills is Amit B. known for?
Amit B. has skills like Medical Devices, R&d, Product Development, Iso 13485, Embedded Systems, Testing, V&v, Program Management, Leadership, Software Development, Design Control, Fda.
Who are Amit B.'s colleagues?
Amit B.'s colleagues are Janna D., Shrineel Patel, Keithania Thomas Pcqi, Benjamin Helmers, Gregory Petrewski, John Arancio, James Prince.
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