Mithil Shah Email & Phone Number

Los Angeles, Ca, Us

Brea, California, Us

Brea, California, Us

Brea, California, Us

Provide communication and achieve collaboration to drive large projects across multiple software teams, as well as building and grow an organization of engineers. Work as an entrepreneur and provide clarity to the team amongst the ambiguity or competing priorities. Work as a hands-on part of the project team to solve challenging situations and come to a solution.

Brea, California, Us

• Experience building and leading a software development team of 15+ through design, delivery and commercialization of custom orthodontic appliances (Aligners/Braces).Drive multiple software development projects end-to-end. Work hand in hand with program management to maintain schedules, track key milestones, program interdependencies, and preempt risks• Technical Product Manager: Lead product vision while managing the development and integration of the multiple software platforms and software applications, end-to-end. Work directly with key stakeholders to understand and craft technical requirements that address business and system needs and issues.• Regulatory Process: Manage all regulatory related processes, documentation, and compliances for 510k approval

Riverside, Ca, Us

UCR Transformative Leadership, Program

Minneapolis, Mn, Us

Technical Lead: Understand the project scope, work with developers to turn it into reality, lead technical resourcing and tracking of tasks. Cross-functional team interaction and prioritizing work in order to get faster to the market. Systems Lead: Work with stakeholders understand the business and clinical needs and turn them into technical documents. Describe the system functionality and coordinate with development and test teams.Test: Create and ensure all the test scenarios are covered. Identify gaps and ensure a quality product developed. Create automation testing along with continuous integration.

Melbourne, Au

• Created requirements specifications and models by evaluating client needs, analyzing use cases and dependencies to support hardware and software development for the software platform consisting of XYZ robot, Gripper, Camera and Barcode reader which can be customized further for client specific needs• Interacted and collaborated with clients to perform activities like feasibility studies, trade analysis, design, and development. Analyze problems involving cross disciplinary aspects of product development to synthesize multiple disciplinary solutions.• Proposed cost reduction for the instrument by performing trade analysis. Suggested alternative hardware and proposed using virtualization to support different operating environment on single hardware. • Build instrument and wrote PLC code to automate a 76 hour process for regenerative medicine and vascular surgery in the cell therapy field. Worked on electrical schematic, wiring and safety reviews for the instrument. • Worked on automating Testing and Data Accusation system for fluid based system consisting of pumps, valves and temperature/pressure sensors, using LabView to build the software.

Brea, California, Us

• Implemented Systems Engineering in the areas of: requirements elicitation and authoring, traceability matrix, risk management matrix, identify system constraints; manage design history files and system level acceptance testing.• Provided Leadership to an offshore software team (Developers and Test) in fulfilling ORMCO and FDA requirements. Develop SOPs establishing efficient procedures. Ensure seamless product integration with timely release of high quality output. Evaluate new technologies; provide technical inputs for research, prototypes and features.• Experience of working in manufacturing and production environment, aided in solving production issues through root cause analysis, taking part in Kaizens, and knowledge of GMP. Developed efficient production processes and documented training manuals and conducted training on new products and processes.• Provide inputs in 510k submissions and FDA clarification request responses.

Minneapolis, Mn, Us

• In-depth experience of testing safety critical medical devices such as insulin pumps, glucose sensors, glucose monitors, RF transmitters, and therapy management web software.• Project lead: Developed complete test plans and verification and validation execution, defect tracking and writing engineering reports for test of hardware, software and firmware.– Provide project status to the PMO, ensure timely completion of project. – Provide inputs to requirements, development, and testing.– Develop tools for testing and simulation. – Provide technical inputs in IFU documentation.• Executed: Unit test, integration test, production test, automated test, black box, white box test and device characterization, HALT and HASS Testing, low level hardware test, and automated testing using quick test pro. • Worked on testing wireless communication over Zigbee (2.4ghz) between medical devices (insulin pump and glucose monitor). The communication involved data package transmission, receiving, CRC check, packet validation, interference check and range check

Northridge, Ca, Us

Provided assistance in Wireless configuration and set up VPN, SSHOffered technical support for computer trouble shooting (hardware and software)

Master Of Science, Electrical & Computer Engineering

Bachelors, Instrumentation & Control Engineering; Biomedical Instrumentation

High School