Jung En (Andrew) Wu

Jung En (Andrew) Wu Email and Phone Number

Jung En (Andrew) Wu's Location
Evanston, Illinois, United States, United States
Jung En (Andrew) Wu's Contact Details

Jung En (Andrew) Wu work email

Jung En (Andrew) Wu personal email

n/a
About Jung En (Andrew) Wu

A vibrant and motivated medical device innovation fellow with excellent communication and organizational skills, who can take initiatives and uniform members within interdisciplinary team environment, to accomplish requirements within schedule objectives. In order to enhance my professional knowledge and expertise that are essential for being an innovation fellow, I joined the Medical Device and Diagnostic Industry (MD+DI) and World Medical Device Organization (WMDO) as a member in 2012. I have completed industry certification courses listed below, - ISO13485 Foundation and Basic Principles- Effective Monitoring of Medical Device Clinical Investigations- Preparing successfully for a US FDA Medical Device Inspection - Health Economic Evaluation of Medical Technologies - The European Union Regulatory System for Medical Devices - ISO 14155 “Clinical Investigation of Medical Device for Human Subjects” in depth review - IEC 62304 Medical Device Software Lifecycle Validation ProcessesI am currently enrolled in the Career Development Program by WMDO, on the way getting the Medical Device Product Lifecycle Certificate. Further, I was invited to attend webinars hosted by MD+MI. The engaging and interactive training environment not only help me gain perspectives from practitioners at all levels, but also helped developing insightful observation, approaches and solutions toward a clinical problem. I look forward to utilize my strong analytical problem skill in a fast paced and challenging environment. Specialties: Biomaterial, Nanomaterial, Medical Device Design and Innovation, Medical Device Life Cycle, Medical Device Regulations, 501(K), GMP/GLP/QSD, ISO10993, ISO13485, Mechanical Testing, Material Characterization, Iron Oxide Nanoparticle, Nanofabrication, CVD

Jung En (Andrew) Wu's Current Company Details
Rook Quality Systems

Rook Quality Systems

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Engineer
Jung En (Andrew) Wu Work Experience Details
  • Rook Quality Systems
    Vp Of Medical Software
    Rook Quality Systems Jan 2024 - Present
    Atlanta , Ga, Us
  • Rook Quality Systems
    General Manager (Apac Office)
    Rook Quality Systems Feb 2020 - Present
    Atlanta , Ga, Us
    Focus on helping clients with technical development, quality and regulatory strategy in the software as medical device space. Current projects include pre-operative surgical planning software, intra-operative software-based monitoring/alert system, CTP dose-reduction algorithm, MR ASL post processing software, Remote Patient Monitoring System for Cardiac Contractility Modulation therapy, EEG wearable, seizure symptom management platform for neurology applications, COPD symptom management platform, wearable intended for detecting arrhythmia, deep learning image-based cancer prediction software, as well as other a number of software as medical device projects.
  • Rook Quality Systems
    Software Quality Assurance Consultant
    Rook Quality Systems Jul 2016 - Jan 2024
    Atlanta , Ga, Us
    Managing Verification & Validation testing and strategy on various medical device embedded software, to ensure conformance to FDA S/W validation guidance and IEC 62304.
  • Twbm - Taiwan Biomaterial Company Limited
    Interim Project Manager
    Twbm - Taiwan Biomaterial Company Limited May 2018 - Jan 2020
    Zhubei City, Tw
    Led the development of aspiration system accessories including suction pump and aspiration tubing set for neurovascular thrombectomy indication from project inception to US market launch in Q2 2019. Assessed and mitigated technical risks and work closely with the Program Manager to consider project risks. Led transfer activities of design to manufacturing plant in Taiwan. Met all milestone deliverables for successful FDA 510K clearance within project contract. Led implementation of new site IQ/OQ/PQ/PPQ Process Validation activities.
  • Twbm - Taiwan Biomaterial Company Limited
    Lead Project Engineer
    Twbm - Taiwan Biomaterial Company Limited Feb 2017 - Jan 2020
    Zhubei City, Tw
    Participated in concept design to design verification & validation activities of a neurovascular guidewire with superior rail-support while maintaining superior navigation capability for neurovascular indications. Evaluated external OEM vendors to assess technical capabilities, workmanship and quality. Analyzed guidewire tolerances in conjunction with delivery catheter tolerances to ensure device compatibility.Website: http://www.twbm.com.tw/
  • Bold Diagnostics, Llc
    Chief Analytics Officer | Co-Founder
    Bold Diagnostics, Llc Nov 2015 - Oct 2016
    Developed non-invasive, continuous vital sign monitor for clinical use. 1. Developed proprietary SVM-based algorithm that extracts pulse waveform features to estimate continuous blood pressure measurement for a variety of clinical applications 2. Helped raise over $330K fund from NSF SBIR Phase I grant and collegiate competitions (Fourth place at 2016 Rice University Business Plan Competition)http://www.bolddiagnostics.com/
  • Center For Healthcare Innovation
    Senior Project Manager
    Center For Healthcare Innovation Dec 2013 - Jun 2016
    Chicago, Illinois, Us
  • Pathfinder Software
    Software Qa Engineer Intern
    Pathfinder Software Apr 2015 - Aug 2015
    Chicago, Il, Us
    User Acceptance Testing; Automation Testing via Calabash and Protractor framework on connective care and wearable solutions.
  • Uroprox Llc
    Lead Engineer | Co-Founder
    Uroprox Llc Sep 2013 - May 2015
    • Accurately identified unmet clinical need in total hysterectomy laparoscopic procedures and developed next generation endopelvic anatomy localization apparatus applicable for all minimally invasive surgeries • Developed high-fidelity prototype based on engineering specifications agreed upon stakeholders’ and compiled design history files in professional manner. • Conducted device verification and validation, evaluated current testing procedures, and optimized manufacturing processes. • Filed provisional patent application and constructed business plan canvas to discover marketing white space.• Company Website: http://uroprox.com
  • Creative Commons Taiwan, Research Center For Information Technology Innovation, Academia Sinica
    Research Assistant
    Creative Commons Taiwan, Research Center For Information Technology Innovation, Academia Sinica Jun 2012 - Aug 2012
    • Developed human-centered Digital Signal Processing chip using NL LabVIEW, aims to improve Chinese speech recognition on cochlear implants by building virtual platforms to discover additional parameters. • Developed Audio Detection Event (ADE) structure in semantic level on healthcare surveillance applications • Published two journal articles in ICAPP 2013 and SITIT 2012

Jung En (Andrew) Wu Skills

Matlab Biomaterials Labview Biomedical Engineering Medical Devices Solidworks Bioengineering Leadership Rapid Prototyping Product Design Strategy Cell Culture Confocal Microscopy Autocad Biotechnology Data Analysis Microsoft Office Fluorescence Microscopy E Commerce Drupal Product Development Finite Element Analysis Design Patents Iso10993 U.s. Food And Drug Administration

Jung En (Andrew) Wu Education Details

  • Georgia Institute Of Technology
    Georgia Institute Of Technology
    Computer Science
  • Northwestern University
    Northwestern University
    Biomedical/Medical Engineering
  • Georgia Institute Of Technology
    Georgia Institute Of Technology
    Material Science Engineering (Minor)
  • Northwestern University
    Northwestern University

Frequently Asked Questions about Jung En (Andrew) Wu

What company does Jung En (Andrew) Wu work for?

Jung En (Andrew) Wu works for Rook Quality Systems

What is Jung En (Andrew) Wu's role at the current company?

Jung En (Andrew) Wu's current role is Engineer.

What is Jung En (Andrew) Wu's email address?

Jung En (Andrew) Wu's email address is jw****@****ech.edu

What schools did Jung En (Andrew) Wu attend?

Jung En (Andrew) Wu attended Georgia Institute Of Technology, Northwestern University, Georgia Institute Of Technology, Northwestern University.

What are some of Jung En (Andrew) Wu's interests?

Jung En (Andrew) Wu has interest in Human Rights, Education, Health.

What skills is Jung En (Andrew) Wu known for?

Jung En (Andrew) Wu has skills like Matlab, Biomaterials, Labview, Biomedical Engineering, Medical Devices, Solidworks, Bioengineering, Leadership, Rapid Prototyping, Product Design, Strategy, Cell Culture.

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