Jean Ann H. Email & Phone Number

San Diego, CA, US

San Diego, California, United States

• A biotech company reimagining therapeutic delivery by creating innovative smart-pill technology for targeted drug delivery to the GI tract and systematic, needle-free delivery of biotherapeutics to improve patients’.
• Developed detailed software requirements for 2 desktop applications written in C++ and Python while the device firmware is written in C by analyzing source code originally developed by a 3rd party.
• Developed, documented and executed detailed Test Protocols by verifying critical-to-safety requirements of the device firmware for IND submission to be complaint with 21 CFR 820, ISO 13485, 62304, 60601 and 14971.
• Executed tests on proprietary equipment including engineering PCB Boards to set up conditions mimicking administration usage prior to patient use for critical to safety testing.
• Completed IQ/OQ/PQ documentation after testing device's installation of firmware, using proprietary software as designed.
• In a GMP compliant Clean Room Lab, installed and tested firmware over 1000 devices and packaged ready for clinical studies for patient usage.

New York City Metropolitan Area

The Soul Cycle, a subsidiary of Equinox Group, is a fitness company offers indoor cycling and spinning workout classes either in studio or online for at home live workout classes. Responsibilities: Organize and mentor a new testing team for the Soul Cycle’s mobile hybrid app on proprietary tablets to ensure each sprint had minimal software bugs for each.

Melbourne, Florida Area

• Teamed up with and supported project and engineering teams to ensure compliance to engineering SOPs and compliant with AS 9100 through project milestones. Closely collaborated with product design authorities and.
• Developed training presentation and conducted training with the entire quality assurance team including managers on how more efficient to use Jama Software to become more efficient in assessing compliance to FAA DO-178.
• Prevented re-engineering of newly overhauled GCP system release of 2020 due to gap analysis by collaborating with Product Design Authorities and System Engineers analyzing architecture and design documentation prior to.
• Maintained AS9100 certification through 2 external audits by guiding the engineering teams to remain compliant with the company's engineering SOPs.
• Trained IV&V team members and managers how to write compliant verification plans for the GCP project along with specific Air Canada and Spirit Airlines projects.

Palm Bay, FL

• Engineering services company providing expertise in various engineering roles for clients’ projects. Provided advice and mentoring remotely and onsite regarding testing methods and concepts to less experienced teams by.
• Prevention of loss of a client’s customers by discovering bugs in the application’s notification handling and excessive battery drainage on software behavior.
• Conducted training of a client’s test team of 15 in system integration testing approaches by conducting simulated exercises on their app prompting testers to develop new test approaches for future releases.

North America With Global Reaches

• Online training entity real time interaction between testers and experienced testing experts in testing concepts, methods, and approaches based on a generalized subject.Developed planned, marketed a topic then.
• Developed over 5 mentoring relationships of testers in mobile app per session of testing techniques, system test integration and test design.

Customized mobile and software product testing services to B2B SaaS companies.Provided leadership support and testing activities for a financial/payroll mobile app with focus on customer user experience, data accuracy and efficient release execution of projects. Collaborated with engineering developers in risk-based testing by attending daily Scrum.

Greater Minneapolis-St. Paul Area

• Organization providing engineering project management, quality assurance, testing, web design and development, business analysis, training and mentoring of process improvement.Implemented and utilized McCabe Software’s.
• Developed a knowledge base of terms, practices and processes for training a new software testing team learning continuous improvement (CI) and continuous development (CD) for applications in a Lean Development Cycle.

Greater Boston Area

Organization provides expertise in medical device engineering and project management.Developed test planning, gap analysis, risk analysis for an insulin pump and monitor system through design reviews, source code reviews and created documentation compliant with 21 CFR 820, ISO 13485 and 62304.

Davie, Florida, United States

Manufacturer of a robotic arm to assist surgeons in performing knee and hip replacements.Conducted gap analysis of software design and software requirements, provided tests for 3rd party software tool used with the robotic arm software. Developed test protocols compliant with 21 CFR 820, ISO 13485, 62304,60601 and 14971.

San Diego Metropolitan Area

• Organization developed a Mobile Cardiac Telemetry diagnostic device system providing cardiac events in real time to physicians. Designed, developed and executed test protocols end-to-end testing of the embedded system.
• Saved patients' lives and the company over $100K in shipping costs and costly lawsuits by discovering a system flaw/limitation in how the heart monitor system behaved by conducting specific load testing on the device
• Saved patients' lives and protected the company from costly lawsuits by discovering a system memory leak in the network protocol software communicating to external servers sending heart data to physicians.
• Passed 2 FDA audits by developed, documented and executed end-to-end system integrated test protocols to be compliant to 21 CFR 820, ISO 13485, 62304, 14971.