Junyu Zhou work email
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•Project manager and Engineer leader with extensive experience in leading projects from idea thru implementation in compliancewith cGMP/ISO/FDA standards and regulations.•Strong project management skills in leading global cross-functional team to develop and commercialize 4+class II/III medical devices with evidence of business impact.•Passionate and innovative engineering and project problems solver to satisfy clinical unmet needs thruapplying solid skills of R&D, quality and manufacturing engineering. 10+ US/China patents.•Skilled in applying project management tools (Gantt, WBS, checklist, business case and financial modelling,planning, and budgeting etc.) for efficient project management.•Resourceful and tactical to synergy ecosystem resources to accelerate R&D project execution (Design house,MKT consultancy, prototyping and testing vendors, CRO, supply chain, CMDO/OEM, NMPA etc.).•Commended for strength in using DFSS tools and statistical methods for product development.
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Project Development Manager碧迪医疗Shanghai, China -
Project Development Manager碧迪医疗 Mar 2019 - PresentShanghai, ChinaEnd to end lead global team to ideation, develop and commercialize multiple complex class II/III devices:Arterial blood safety device, Safety blood collection device, Laparoscopic hemostatic Applier, Insulin smart injector, RFID blood tube. Capillary blood acquisition, Digitalized Biologic combination Prefilled syringes. • Develop innovation/localization strategy and project opportunities scouting and validation. Strategic alignment with senior management to win endorsement and sponsor. •Work with cross function team to develop project IP,R&D,regulatory,clinical,quality,manufacturing and reimbursement strategy. Develop project plan, identify dependency, craft and assess timeline and budget estimate. Analyze critical path, risks, and constraints, Identify resources and stakeholders. •Execute multiple projects from ideation, to launch in accordance with agreed specifications, time, cost and staffing. Coaching and appraisal project member performance to hierarchical superiors. •Work with RA to prepare submission dossier and follow through the NMPA discussion and registration process. • BD R&D Ecosystem building: innovation summit. Work with incubators to host multiple bio-design bootcamps. •Commercialization strategy to launch product in China/global market. -
Senior R&D Engineer碧迪医疗 Mar 2017 - Mar 2019Suzhou, Jiangsu, China -
Mechanical Design EngineerMedtronic Mar 2013 - Mar 2017Shanghai City, ChinaExtensive R&D design and engineering of multiple surgical devices thru all phases of the product-developmentlifecycle, from conceptualizing to production rolling out.Developed products: Colorectal Circular stapler, Hemorrhoid stapler, Vessel sealing device, Hernia fixationdevice. Powered stapler.•User needs analysis and international VOC and competitor benchmark test to acquire inputs/specifications.•Concept generation, modelling and drawings to deliver a variety of critical sub-assemblies (sheet metal, CNC,die-casting and injection molding parts, 3D printing). Medical packaging and artwork design.•Usability formative and summative study.•Setting up Pilot assembly line in lab.•Develop risk-based design verification protocol and report.•Supplier management and contact vendor for multiple material vendors. •Develop mass manufacturing line. IQ/OQ/PQ.•Clinical in-vitro and in-vivo testing and support regulatory on regulatory submissiondossier (CER, PTR, type testing etc.).
Junyu Zhou Skills
Junyu Zhou Education Details
Frequently Asked Questions about Junyu Zhou
What company does Junyu Zhou work for?
Junyu Zhou works for 碧迪医疗
What is Junyu Zhou's role at the current company?
Junyu Zhou's current role is Project Development Manager.
What is Junyu Zhou's email address?
Junyu Zhou's email address is ju****@****nic.com
What schools did Junyu Zhou attend?
Junyu Zhou attended Shanghai Jiao Tong University, Harbin Institute Of Technology.
What skills is Junyu Zhou known for?
Junyu Zhou has skills like Mechanical Product Design, Medical Device R&d, Dfss, Design Of Experiments, Design Verification Testing, 3d Modeling, Computer Aided Design, Design Failure Mode And Effect Analysis, Voice Of The Customer Analysis.
Who are Junyu Zhou's colleagues?
Junyu Zhou's colleagues are Dara Severino, Gábor Varga, Matt Keller, Pooyuda Phinongram, Laura Angélica González Martínez, Travis Hobbs, 韦定谷.
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Junyu Zhou
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