BDxConnect Cloud Platform with Bardy Diagnostics

*Design protocols and tools for AED Software verification and validation. Specializing in algorithms and software tools.*Develop and execute test plans for new products and product updates. Ensure coverage for hardware, software, and usability. Managing quality systems and regulatory frameworks.*Lead cross-functional teams for audit remediation and high-impact CAPAs.

*Developed custom algorithms and analysis protocols for researchers with innovative and unsolved microscopy data. Analyzed microscopy image data using state-of-the-art software platforms to solve real problems in the life sciences*Wrote extensive technical and software support documentation in creating and updating customer-facing wiki page for all software features, including video and text tutorials, and internal writing and design support procedures. *Ensure customers ability to analyze images and realize optimal results by supporting for SVCell, Aivia, and CL-Quant. Delivered technical support for live streaming, video editing, and software setup by participating in customer-facing marketing activities, such as webinars.*Cultivate rapport and build positive relationships with new and potential customers to facilitate advancement through sales pipeline.

*Performed verification of system requirements for portable ultrasound systems including software design, transducer functionality, DICOM reporting, and Triplex (BCD) ultrasound recording and reported bugs using Agile document control methods and IBM Rational Change and Rational DOORS software*Ensured testing methods for medical ultrasound devices met the necessary system specifications as outlined by a formal testing plan – improved verification procedure accuracy by 40%*Worked with FPGA and function generator based solutions to improve test procedure accuracy and reduce testing material costs by up to 50%*Familiar working under EN ISO 13485, ISO 14971, ISO 9001:2000, 21 CFR 820, EU Medical Device Directive, CMDCAS, and Ministerial Ordinance No.169

Member of the Shain Research Group and Center for Integrative Brain Research at Seattle Children's Research Institute as a graduate student in the Department of Bioengineering*Developed software approaches for analyzing complex neuroscientific inquiries – improved SNR by 17% over standard protocols, decreased researcher involvement in software chain by 85%, and reduced processing time by over 30% *Reduced risk of device failure by 12% by designing an improved protocol for insertion of neuroprosthetic devices *Experiments involved animal surgery, immunohistochemistry and histology, light microscopy, advanced computer imaging, and complex image analysis – throughput of 2000+ tissue samples and analysis of 200+ imaging data setsPublications:Hanak BW, Hsieh C-Y, Donaldson W, Browd SR, Lau KKS, Shain W. 2017. Reduced cell attachment to poly(2-hydroxyethyl methacrylate)-coated ventricular catheters in vitro. J Biomed Mater Res Part B 2017: 10.1002/jbm.b.3391

*Graded and maintained records of all exams, assignments, labs, and presentations for Medical Imaging course*Available to help students with material and assignments - offered tutoring in ultrasound, x-ray, CT, MRI, optical coherence tomography, and nuclear imaging*Created and maintained online class material, including website, schedules and syllabus.

*Harvested and screened protein samples for crystallography and upscale of drug targets – responsibilities included cell culture, differential centrifugation, His-tag protein purification, Western blotting and gel electrophoresis*Prepared media, maintained laboratory equipment, and ensured a sterile laboratory environment – familiar with autoclave use, care of standard glassware, and sterilization procedures for lab surfaces*Trained five new employees in Good Laboratory Practices, essential lab techniques and protocols, and sterile cleaning procedures

*Developed software interfaces between MATLAB and experimental research devices including BCI2000, Arduino, Phantom Omni, Microsoft Kinect, and Emotiv Epoc *Wrote MATLAB modules to interact with device drivers written in C++ and Java