Sigalit Tsadok Email & Phone Number

Fractional CTO services as well as project-based consulting services (projects listed below – longer projects include dates)• CTO of Kelvi (Hypothermia Devices, Inc) (2017 - present) Responsible for software production strategy, team building, technology transfer, architecture, cyber security, standards compliance, embedded linux, Qt/QML, firmware. Oversee all software activities for Class II medical device.• Installing Software Design Controls for Class II medical devices • Technology services for knowledge transfer from PetWireless to Nestlé Purina (2019 - present)• Commercialized firmware for pet technology IoT startup, manage product development for Pet Wireless, Inc. (Sep 2015 – 2017)• IEC 80001-1:2010 project – Collaborated with Scripps Hospital Bioengineering and IT departments through the Center For Medical Interoperability to developed reusable tools, templates, processes, SharePoint site for risk mgmt. of medical IT networks, (hospital networks that support wireless medical devices). IT risks, security, availability, reliability, etc. (Jul 2014 – Sep 2015)• Led team and designed, developed, launched responsive commercial website for local winery using HTML5, CSS3 and jQuery, git.• Compiled, submitted, and received FDA 510(k) clearance for Sotera Wireless ViSi, a wireless medical vitals signs system.• Customized JIRA to automate Sotera Wireless quality system workflows - needs-based development through owner interaction.

Technical co-founder, President, and CTO of a building industry startup that focuses on SaaS solutions for building industry problems.Tech stack:Frontend: React/Redux Back end: Golang / Node.js / Postgres / PythonOther: AWS; Stripe, Auth0 and other 3rd party integration

Inglewood, California, Us

Tech Stack:Embedded development - Yocto, Open Embedded linux OS, QT, QML, Python, C++, C, ArduinoMobile App - Xamarin (iOS / Android) with Azure PipelinesOther: AWS, Azure, MySQL

Harbor View Solutions provided services. Responsible for all aspects of product development (HW, SW, ME, including initial manufacturing, SOPs, and product support). Managed schedule and roadmap for product development, analytics.• Collaborate with Marketing, Data Analytics, Manufacturing and Operations to align activities in fast paced environment to meet rapid pivots of strategic goals for early sales, Kickstarter fulfillment, gather beta feedback, and provide fundraising support.• Manage remote/on-site teams using best practices for multiple beta releases to meet business needs, feedback, and field testing.• Hire, train, coach, mentor, run manufacturing team, run development team (cloud-hosted Ubuntu server, Golang backend application, Couchbase NoSQL document based DB, data analytics, mobile platform: iOS, Android, firmware for Wi-Fi connected IoT device).• Team up with CEO and Marketing to develop, implement, and prove recurring revenue models (“free-mium”, Vet partner program)• Write SOPs, ran first 1000 build, transferred development to initial on-shore CM, identify and transfer development to off-shore CM

Carlsbad, California, Us

Prioritized and managed hospital and partnership projects for ViSi Mobile integration into EHRs, secondary alarming solutions, and custom applications. • Supported customized hospital integrations, on-site collaboration with Cerner and hospital project managers to build and test solutions for hospital medical device and server integrations. Planned testing with IT and PM teams, cut-over testing and support.• Supported backend server customizations (beds, alarm limits, etc.) for each deployment in a change-controlled environment (on-site Ubuntu server, with HW redundancies, Java backend and client side applications, PostgreSQL DB, pub-sub architecture, set of APIs for clients)• Strategized and led initiatives that complemented ViSi Mobile’s continuous vital signs to position Sotera as a thought leader in alarm management in rapidly changing, yet change-controlled environment.

Carlsbad, California, Us

Product development (software and SW QA) and manufacturing automation. Established departmental budgets, schedules for delivery, product roadmap and business forecasts and goals in challenging transitional period through rapidly changing priorities and organizational restructures.• Collaborated with server-client software and SQA teams to establish hold Agile sprints/SCRUMS for coordinated software releases.• Participated in strategic planning of product releases and product rollout strategy; set metrics for team performance and SW quality• Managed development and process validation of automation software for ISO 13485 regulated manufacturing stations for the assembly and testing of the ViSi components. • Oversaw interoperability, coexistence, and wireless load testing in compliance with FDA Guidance for Radio-Frequency Wireless Technology in Medical Devices. Received FDA 510(k) clearance in 73 days. Negotiated schedule and cost with external test groups

Carlsbad, California, Us

Established and managed a department responsible for all software and hardware verification activities for the ViSi Mobile (patient-worn, multi-parameter vital signs monitor).• Identified, hired and trained new team of permanent employees as well as outside contractors and consultants in an as-needed basis saving the company over $150,000/yr in personnel expenses.• Managed multiple rounds of product testing for multi-parameter vital signs monitoring system in 8 months to get to FDA submission.• Ensured compliance with IEC, AAMI, ISO standards for ECG, SpO2, NIBP including all collateral and particular standards, environmental requirements, and general safety required for FDA 510(k) and CE mark.• Developed verification plans, processes and tools for all SW-related projects, sustaining engineering activities, continuous integration. • Received 2011 Founder’s Award for recognition of role in the company’s receipt of first 510(k) clearance for ViSi Mobile.

Pacific Software Management is a company that I recently formed for independent consulting to Medical Device manufacturers.My focus is on bringing best software practices and methodologies to software development teams as a means of improving quality, time to market, and customer satisfaction. Process improvement and adherence to FDA guidelines and ISO and other industry standards are my specialties.

Bothell, Wa, Us

Ensured the smooth transition of software engineering knowledge and tools to the appropriate team members at SonoSite. Continued to manage any CardioDynamics product-related development or issues. Worked with Manager of Software Process and Quality and assisted in management of overseas engineering resources.

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Responsible for all product software, budgeting, personnel hiring, managed 4 person software team, softwaredevelopment, software testing, design controls per quality system.• Managed project and engineering teams to upgrade main commercial product, driven by inventory depletion of end-of-life legacy platform. Projectincluded complete GUI redesign, conversion to Windows XP Embedded, using C# .NET, redesign of custom medical-grade cart with a final designat $200 per cart. Cross-functional team included engineering, marketing, purchasing, manufacturing, quality and customer service. FDA 510(k)cleared in 89 days with no inquiries.• Adopted Agile methodology practices to SW development process – SCRUM, user stories, sprint planning, backlog prioritization. Improved schedulepredictability by 80%, and allowed team to respond quickly to changing requirements.• Developed software for additional revenue sources from pharmaceutical CROs and OEM customers (including Mindray and GE).

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Managed software projects, contributed to software development.• Managed sustaining engineering SW development project; reduced the occurrence of SW-specific field complaints by over 80%. • Managed SW releases for a multi-million dollar clinical studies to demonstrate the use of the BioZ DX to control hypertension.• Wrote extensive C++ UI code for real-time embedded Windows CE BioZ Dx ICG system (generated over $33 million in sales)• Wrote, debugged, and tested new features on a page-switched Analog Devices 2187n DSP chip with increased memory space.• Created and maintained processes in compliance with FDA and ISO Quality System Regulations that enhanced SW quality.• Developed design and verification documentation for the Windows CE UI and the Analog Devices DSP software.

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• DSP processor SW design and development of waveform processing and fiducial point detection with wavelet filtering using Analog Devices 2181, and 2185 chipset. • Assembly level code for an ICG custom module for the GE Marquette GE Marquette Solar Systems still being sold and used in the US hospital market today. Updated DSP code for the redesign of the CardioDynamics BioZ System. Analog Devices assembly language, VisualDSP++, CodeWright, PVCS• Embedded Visual C++ and MFC, state machine control of complex events handling, handshaking, data transmission, and errors and faults during a patient monitoring session. • Software requirements, software design specifications, test protocols, traceability matrices, build procedures, code reviews, version control.• Verification and validation of product software and firmware including all relevant software documentation.

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• Signal processing and algorithm development to improve correlation with excepted techniques.• Use of simple mathematical modeling, waveform database maintenance and data collection, SW tool development, technical support, preparation of presentations, FDA and engineering documentation, verification and validation of product software.Publications at CardioDynamics:Tsadok, S. (1999). The Historical Evolution of Bioimpedance. AACN Clinical Issues, Vol. 10 3:371-384.Verhoeve PE, Cadwell CA, Tsadok S. (1998) Reproducibility of noninvasive Bioimpedance measurements of cardiac function. Journal of Cardiac Failure.1998:4(3)(suppl):53.

Ms, Bioengineering

Bs, Bioengineering