Vp Of Medical Software
Current
Jan 2024 - Present
AeroLeads people directory · profile
Jung En (Andrew) Wu Email & Phone Number
Engineer
at
Rook Quality Systems
1 work email found
@gatech.edu
LinkedIn matched
✓ Verified August 2026
4 data sources
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Who is Jung En (Andrew) Wu? Overview
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Quick answer
Jung En (Andrew) Wu is listed as Engineer at Rook Quality Systems, based in Evanston, Illinois, United States. AeroLeads shows a work email signal at gatech.edu and a matched LinkedIn profile for Jung En (Andrew) Wu.
Jung En (Andrew) Wu previously worked as VP of Medical Software at Rook Quality Systems and General Manager (APAC Office) at Rook Quality Systems. Jung En (Andrew) Wu holds Master'S Degree, Computer Science from Georgia Institute Of Technology.
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*@gatech.edu
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Profile bio
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
Listed skills include Matlab, Biomaterials, Labview, Biomedical Engineering, and 21 others.
Current workplace
Jung En (Andrew) Wu's current company
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10 roles
Jung En (Andrew) Wu work experience
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General Manager (Apac Office)
CurrentFocus 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.
Feb 2020 - Present
Software Quality Assurance Consultant
Managing Verification & Validation testing and strategy on various medical device embedded software, to ensure conformance to FDA S/W validation guidance and IEC 62304.
Jul 2016 - Jan 2024
Interim Project Manager
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.
May 2018 - Jan 2020
Lead Project Engineer
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/
Feb 2017 - Jan 2020
Chief Analytics Officer | Co-Founder
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/
Nov 2015 - Oct 2016
Senior Project Manager
Dec 2013 - Jun 2016
Software Qa Engineer Intern
User Acceptance Testing; Automation Testing via Calabash and Protractor framework on connective care and wearable solutions.
Apr 2015 - Aug 2015
Lead Engineer | Co-Founder
Uroprox Llc
• 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
Sep 2013 - May 2015
Research Assistant
• 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
Jun 2012 - Aug 2012
4 education records
Jung En (Andrew) Wu education
Master'S Degree, Computer Science
Georgia Institute Of Technology
Master Of Science (M.S.), Biomedical/Medical Engineering
Northwestern University
Bachelor Of Science (B.S.), Biomedical Engineering, Material Science Engineering (Minor)
Georgia Institute Of Technology
Education record
Northwestern University
FAQ
Frequently asked questions about Jung En (Andrew) Wu
Quick answers generated from the profile data available on this page.
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 Rook Quality Systems?
Jung En (Andrew) Wu is listed as Engineer at Rook Quality Systems.
What is Jung En (Andrew) Wu's email address?
AeroLeads has found 1 work email signal at @gatech.edu for Jung En (Andrew) Wu at Rook Quality Systems.
Where is Jung En (Andrew) Wu based?
Jung En (Andrew) Wu is based in Evanston, Illinois, United States while working with Rook Quality Systems.
What companies has Jung En (Andrew) Wu worked for?
Jung En (Andrew) Wu has worked for Rook Quality Systems, Twbm - Taiwan Biomaterial Company Limited, Bold Diagnostics, Llc, Center For Healthcare Innovation, and Pathfinder Software.
How can I contact Jung En (Andrew) Wu?
You can use AeroLeads to view verified contact signals for Jung En (Andrew) Wu at Rook Quality Systems, including work email, phone, and LinkedIn data when available.
What schools did Jung En (Andrew) Wu attend?
Jung En (Andrew) Wu holds Master'S Degree, Computer Science from Georgia Institute Of Technology.
What skills is Jung En (Andrew) Wu known for?
Jung En (Andrew) Wu is listed with skills including Matlab, Biomaterials, Labview, Biomedical Engineering, Medical Devices, Solidworks, Bioengineering, and Leadership.
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