Jung En (Andrew) Wu work email
- Valid
Jung En (Andrew) Wu personal email
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
-
Vp Of Medical SoftwareRook Quality Systems Jan 2024 - PresentAtlanta , Ga, Us -
General Manager (Apac Office)Rook Quality Systems Feb 2020 - PresentAtlanta , Ga, UsFocus 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. -
Software Quality Assurance ConsultantRook Quality Systems Jul 2016 - Jan 2024Atlanta , Ga, UsManaging Verification & Validation testing and strategy on various medical device embedded software, to ensure conformance to FDA S/W validation guidance and IEC 62304. -
Interim Project ManagerTwbm - Taiwan Biomaterial Company Limited May 2018 - Jan 2020Zhubei City, TwLed 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. -
Lead Project EngineerTwbm - Taiwan Biomaterial Company Limited Feb 2017 - Jan 2020Zhubei City, TwParticipated 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/ -
Chief Analytics Officer | Co-FounderBold Diagnostics, Llc Nov 2015 - Oct 2016Developed 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/ -
Senior Project ManagerCenter For Healthcare Innovation Dec 2013 - Jun 2016Chicago, Illinois, Us -
Software Qa Engineer InternPathfinder Software Apr 2015 - Aug 2015Chicago, Il, UsUser Acceptance Testing; Automation Testing via Calabash and Protractor framework on connective care and wearable solutions. -
Lead Engineer | Co-FounderUroprox 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
-
Research AssistantCreative 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
Jung En (Andrew) Wu Education Details
-
Georgia Institute Of TechnologyComputer Science -
Northwestern UniversityBiomedical/Medical Engineering -
Georgia Institute Of TechnologyMaterial Science Engineering (Minor) -
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.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial