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• Technically sophisticated and goal-oriented with proven records of product development, program management and quality engineering in surgical robots, implantable medical devices and drug/device combination products• Track of record in successful early-stage innovation, technology development, quality management system set up, process development/transfer and commercialization in both small/entrepreneurial and large global company environments• Deep knowledge and more than 10 years of hands-on experience in product development, quality system establishment/maintenance, operation and regulatory submission of various medical devices in China• Subject matter expert on combination products, pharmaceutical CMC, polymer and other biomaterials for device applications from product development, quality control to regulatory submissions• Led cross-functional teams, managed and coached team members on problem solving, people and project management skills• Fast learner and strategic decision makingSpecialties: Surgical robotsClass-III Medical DevicesDrug Device Combination Products Controlled ReleasePharmaceutical CMCProgram Management and Product Development Process (PDP)Personnel ManagementMaterial Bulk and Surface Structure Analysis
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DirectorIntuitive Apr 2021 - PresentCalifornia, 94086, UsLead Engineering team with responsibilities in the area of Product Engineering, Quality Engineering and Program Management to support new product introduction and localization of minimal invasive surgical robotic product platforms in China -
Senior ManagerIntuitive Mar 2018 - Mar 2021California, 94086, Us• Manage a technical team to lead the engineering activities related to the product localization, technical compliance and registration of Intuitive’s product portfolio in China• Manage R&D activities and lead the technology transfer of a novel robotic system for minimal invasive lung cancer diagnosis, drive the set up of design control framework and co-managed the R&D team in a local partner in China with manufacturing and R&D capability• Manage overall project timeline and drive team deliverables for the product transfer to the local partner• Manage the preparation of product technical requirement documents, the interaction with NMPA test lab and the execution of type testing for product registrations in China• Functional management and strategically grow team capability to support rapidly expanding goals and objectives -
Senior Program ManagerMedtronic Jul 2017 - Mar 2018Minneapolis, Mn, Us• Cross-functional core team lead and managed the trans-radial access product portfolio with responsibility over program strategy, finance, product development, production, Quality, Regulatory and other cross-functional activities -
Senior Principal R&D Engineer/Core Team LeadMedtronic Jul 2014 - Jul 2017Minneapolis, Mn, Us• Cross-functional core team lead of Medtronic's new generation of drug-coated balloon for coronary indication, responsible for overall project P&L and decision making, and provided the program status updates to Business Unit GM and the Senior Staff • Managed cross-functional core team, including core team members from R&D, PMO, Marketing, finance, QA, RA and Manufacturing, and owned overall project scope, timeline, resource and risk• Technical consultant on the development of novel drug-eluting stent platform for commercialization in multiple geographies• People manager of R&D engineers and technicians supporting various new product development projects -
Sr. Principal R&D Engineer/Program ManagerMedtronic Dec 2012 - Jul 2014Minneapolis, Mn, Us• Expatiated to China and worked as R&D program manager and core team member supporting strategic alliance between Medtronic and Lifetech, a leading Chinese cardiovascular device company• Collaborated with the local partner in the product development, manufacturing and commercialization of bioprosthetic heart valve to serve the value segment of structure heart market in China • Managed the overall R&D project timeline and collaborated technical and cross-functional teams from multiple sites across US and China on design and quality system update, product testing, design validation/verification, technical review and other key PDP, quality and launch deliverables under aggressive schedules• Supported the strategy and monitored the progress of the regulatory submission of heart valve product and accessories to Chinese FDA (CFDA) and addressed questions from CFDA reviewers and test centers• Initiated and executed the efforts to support a CFDA Test Center to establish valve testing capability, which doubled the number of certified testing center and accelerated the regulatory approval for Medtronic's structural heart products in China• Supported CFDA in adopting the ISO 5840-3 (ISO transcatheter heart valve standard) in China, addressed their questions and participated the CFDA standard committee meeting to establish Chinese national requirements (GB) for transcatheter valve products • Managed and coached R&D manager and engineers from local partner on PDP process, concept and tools used for project planning, progress tracking and resource management -
Senior Principal R&D EngineerMedtronic Jun 2011 - Dec 2012Minneapolis, Mn, Us• Key R&D lead and core team member in developing Medtronic's flagship Resolute Integrity DES program, obtained FDA approval in Feb. 2012 and PMDA approval in Sept. 2012 with $1B+ annual revenue• Provided expert opinion and guidance on chemistry, biomaterials, drug elution and CMC topics for FDA and PMDA submission of DES products in US and Japan• Represented Medtroinc to present DES, DCB and renal denervation products on CFDA panel meetings for the product submission in China• Collaborated with regional and global marketing team in seeking unmet clinical need in China and product pipeline opportunities for the value segment of China and other emerging markets -
Principal R&D EngineerMedtronic Feb 2008 - Jun 2011Minneapolis, Mn, Us• Managed several key cross-functional projects, monitored/reported progress against aggressive milestone schedules for Resolute Integrity DES program• Resolved complex technical issues related to manufacturing process to mitigate the impact of production challenges on revenue loss • Evaluated and developed novel hydrophilic coating as technology platform for newer generation of stent, balloon and aspiration catheters • Colloborated with preclinical group to design animal studies to investigate the in-vivo drug elution and pharmacokinetics of Resolute DES and evaluated in-vivo in-vitro correlation (IVIVC)• Partnered with marketing/sales/clinical departments and traveled to customers in US, Japa, China, Latin America for product launch and facilitating Voice of Customer (VOC) and applying DRM into product development• Heavily involved with regulatory strategy development, supported regulatory submissions, communicated with regulatory bodies from different geographies, including FDA, European, Japan, Canada, China and Asia Pacific regulatory agencies, and addressed their technical questions • Evaluated, managed and worked tactfully with suppliers to ensure an uninterrupted supply of critical raw materials and timely resolution of technical challenges -
Senior R&D EngineerMedtronic Nov 2005 - Feb 2008Minneapolis, Mn, Us• Product development of Resolute Zotarolimus-eluting stents (DES) • Led technical projects to inestigate and optimize various manufacturing processes on key device characteristics • Development and in-depth characterization of DES coating and the impact on drug elution properties• Provided technical support to regulatory filings in Europe and obtained CE mark in Oct. 2007 -
Senior ScientistIcbm Aug 2004 - Nov 2005• Led a technical team in developing novel nano-coating material for applications in construction materials from concept generation, technology development, pilot trial to manufacturing • Managed junior scientist and engineer and facilitated their development in technical and project management skills • Cooperated with a global leading company in technology transfer and joint process development, and responsible for business/research planning, timeline tracking and technical communications• Identified/developed key intellectual properties and tracked IP development from competitors
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ScientistSipix Imaging Feb 2003 - Aug 2004Fremont, Ca, Us• Early-stage technology development of polymer encapsulated colloid formulations of electrophoretic display (EPD) for e-paper and e-book applications • Developed coating materials for EPD with enhanced visual appearance for fully-flexible TFT and passive matrix e-book -
Research InternOmnova Solutions May 2002 - Feb 2003Beachwood, Oh, UsConducted the structure-property characterization of various performance coating products for formulation/process development and product defect analysis -
Research InternFirestone Nov 2000 - Sep 2001UsInvestigated the morphology and nano-mechanical properties of various advanced materials for automobile and construction material applications -
Senior Research AssociateP&G (China) Jul 1997 - Jul 1998• Development of market leading fabric care and oral care products
Xin Weng Skills
Xin Weng Education Details
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The University Of AkronPolymer Science -
Stanford UniversityStanford Certified Project Manager -
Fudan UniversityMaterials Science
Frequently Asked Questions about Xin Weng
What company does Xin Weng work for?
Xin Weng works for Intuitive
What is Xin Weng's role at the current company?
Xin Weng's current role is Director at Intuitive.
What is Xin Weng's email address?
Xin Weng's email address is xi****@****nic.com
What is Xin Weng's direct phone number?
Xin Weng's direct phone number is (800) 633*****
What schools did Xin Weng attend?
Xin Weng attended The University Of Akron, Stanford University, Fudan University.
What skills is Xin Weng known for?
Xin Weng has skills like R&d, Medical Devices, Design Of Experiments, Biomedical Engineering, Fda, Biomaterials, Materials Science, Commercialization, Polymers, Product Development, Research And Development, V&v.
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