Summary
Overview
Work History
Education
Skills
References
Timeline
Generic

SIVAKUMAR KARNATI

Canoga Park

Summary

Results-driven professional with 20+ years of experience in the medical device industry, specializing in software development, Agile implementation, and cross-functional leadership. Proven track record of scaling Agile practices using the Scaled Agile Framework coaching teams and delivering high-quality, FDA-compliant products. Strong technical background in embedded systems, neuromodulation, and innovative vision technology. Recognized for driving complex projects in regulated environments from concept through clinical trials with precision and quality. Strong track record of fostering collaboration, continuous improvement, and rapid adaptation to changing markets and regulatory demands. Consistently recognized and tasked to develop high priority projects implementing EMR Integration with Epic, AllScripts for Blood Vitals, ECG and Spirometry products, Retinal Visual Prosthesis implant for blind patients, SCS, and DBS implants for Chronic Back Pain, and Parkinson patients.

Overview

20
20
years of professional experience

Work History

Software Consultant/Business Development

Klassik Soft Solutions, Inc
Canoga Park
01.2024 - Current
  • Technologies Used: VS2019, .NET, C, C++, C#, WPF using MVVM architecture, Design Patterns, HTML, CSS, JavaScript, XML, XAML, SQL Server 2019, LINQ, Entity Framework, ASP.NET, .NET Core, Web API, Rest API, Windows Forms, USB-C, Bluetooth BLE communication, Multi-threading, Async, TPL, TDD, Unit and Integration testing, FxCop, StyleCop, Moq, MS-Project, GitLab, DevOps, CI/CD, GitHub Actions, Module Design, Development, Unit and Integration testing
  • Participated in sprint planning, daily stand-ups, sprint reviews, retrospectives, and system demos.
  • Collaborated with Product owners and stakeholders to prioritize and align deliverables with strategic business goals.
  • Supported cross-functional team coordination and dependencies ensuring timely delivery.
  • Developed Rest API endpoints for data acquisition from various sensors to store the sensor data locally or to the cloud database on demand.

Software Engineer - III

Midmark Corporation
Pasadena
01.2023 - 12.2023
  • Technologies Used: Scaled Agile Framework SAFe, Jira, VS2019, .NET, C#, C++, WPF using MVVM architecture, EMR Integration with Epic and AllScripts, Design Patterns, HTML, CSS, JavaScript, XML, XAML, SQL Server 2019, LINQ, Entity Framework, Telerik Controls, SCI Chart, Web API, Windows Forms, USB communication, Multi-threading, Async, TPL, TDD, Unit and Integration testing, FxCop, StyleCop, Moq, MS-Project, MS Azure DevOps, CI/CD, GitHub Actions, Change management, Jama Software for Requirements
  • Participated in all scrum ceremonies including daily stand-ups, sprint planning, backlog grooming, sprint reviews, retrospectives, and system demos.
  • Collaborated with Product owners and stakeholders to prioritize backlogs, refine user stories, and align deliverables with strategic business goals.
  • Utilized Jama application for requirements management of system-level requirements.
  • Supported cross-functional team coordination and dependencies ensuring timely delivery of critical features.
  • Used Jama to manage requirements, track changes, and plan releases.
  • Ensured compliance with FDA regulations and ISO standards while maintaining Agile flexibility and adaptability in product development cycles.

Principal Software Engineer and Agile Lead

Golden Eye Bionics
Pasadena
01.2020 - 12.2022
  • Technologies Used: Visual Studio, Expression Blend, C, C++, C#, WPF using MVVM architecture, SQL Server, Design Patterns, Non-GOF patterns, HTML, CSS, XML, XAML, ASP.NET, REST API, SQL Server, LINQ, Entity Framework, Code Trigger, Web API, Windows Forms, RF, USB-C & BLE Device communication, Multi-threading, Async, TPL, Unit and Integration Testing, FxCop, StyleCop, Moq frameworks, ReSharper, AWS RDS, S3, UML using PlantUML and Altova UModel, JIRA, Jama, MS-Visio, MS-Project, GitLab, DevOps CI/CD, Code Reviews, PDM software - Qualitize, Jama, Agile Scrum Process
  • Accountable for Architecting, Designing and Developing Software Product for Bionic Eye – Visual Prosthesis retinal implant product supported by various external devices.
  • Delivered initial release of the Diagnostic And Configuration Software - DAC, for Bionic Eye, Visual Prosthesis retinal implant product as per the company’s plan and objectives with high quality.
  • Cross-functional collaboration with other teams such as product manager, hardware, firmware to develop necessary communication protocols.
  • Led the delivery of documents pertaining to: Requirements, Architecture, Module Design, Code Reviews, Unit and Integration tests, Traceability matrix, User and Design FMEA, Risk Analysis and Risk management.

Senior Software Engineer

Boston Scientific (Neuromodulation Division)
Valencia
01.2006 - 12.2018
  • Technologies Used: VB6, COM/DCOM, MS Access, Visual Studio, Expression Blend, C, C#, C++, WPF using MVVM architecture, Design Patterns, Non-GOF patterns, PRISM framework, HTML, HTML Help Workshop, CSS, XML, XAML, SQL Server, LINQ, Entity Framework, SSRS, Web API, Windows Forms, RF Device Communication, Multi-threading, C++, InstallShield, VSS, TFS, Unit and Integration frameworks, FxCop, StyleCop, Moq frameworks, ReSharper, UML, JIRA, MS-Visio, MS-Project, Code Collaborator, Rational Rose, Clear Quest, Requisite Pro, PDM software, Agile Scrum Process, Global UDI
  • Accountable for Architecting, Designing and Developing Software Products: Spinal Cord Stimulation and Deep Brain Stimulation.
  • Supported various releases of the product to obtain FDA Approval.
  • Cross-functional collaboration with other teams such as marketing, product manager, hardware, firmware, software to develop necessary communication protocols.
  • Led the delivery of UDFMEA Risk Analysis and Risk management, Code Reviews, Document Management and UDI database for approval and release for compliance.

Education

Certificate - C, C#, Design Patterns, SQL Server Reporting Service

University of California, Los Angeles

Honor’s Diploma - Systems Management

NIIT
Hyderabad, India

Master of Science - Physics

University of Madras
India

Bachelor of Science - Physics

University of Madras
India

Skills

  • Medical Device System & Solution Architect
  • Visual Studio
  • Git
  • WPF
  • C#
  • C
  • C
  • Visual Basic
  • Python
  • HTML
  • CSS
  • XAML
  • Javascript
  • TypeScript
  • ASP Net & Core
  • MS Access
  • SQL Server
  • PostgreSQL
  • MySQL
  • Amazon RDS
  • S3
  • MongoDB
  • Design Patterns
  • MVVM
  • MVP
  • MVC
  • Linux
  • Jira
  • Jama
  • Confluence
  • Azure DevOps
  • GitHub Actions
  • CI/CD
  • Docker
  • Unit and Integration
  • Install Shield
  • TFS
  • VSS
  • AI & ML
  • Layered
  • Monolithic
  • Rest API
  • Event Driven
  • Microservices Distributed Architecture
  • Medical Device SDLC
  • Requirements collection
  • Architecture
  • Module Design
  • Unit testing
  • Integration testing
  • Verification and Validation
  • User/Design FMEA
  • Risk Management
  • Global Unique Identifier
  • Document Control
  • FDA Compliance
  • ISO Compliance
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • 21 CFR Part 820
  • Embedded Systems Support
  • RTOS
  • Architecture/interfaces
  • Communication protocols
  • CAN
  • UART
  • SPI
  • I2C
  • RS485
  • Bluetooth
  • BLE
  • Test & measurement
  • Oscilloscope
  • Logic Analyzer
  • Programmable power supply
  • DMM
  • Packet sniffers
  • EMR
  • Visual Prosthesis
  • Spinal Cord Systems
  • Deep Brain Stimulation Systems
  • Cross-functional Team Leadership
  • Technical Project Management
  • Change Management
  • Agile
  • SAFe Implementation
  • Scrum Facilitation
  • Team Coaching

References

Available on Request

Timeline

Software Consultant/Business Development

Klassik Soft Solutions, Inc
01.2024 - Current

Software Engineer - III

Midmark Corporation
01.2023 - 12.2023

Principal Software Engineer and Agile Lead

Golden Eye Bionics
01.2020 - 12.2022

Senior Software Engineer

Boston Scientific (Neuromodulation Division)
01.2006 - 12.2018

Certificate - C, C#, Design Patterns, SQL Server Reporting Service

University of California, Los Angeles

Honor’s Diploma - Systems Management

NIIT

Master of Science - Physics

University of Madras

Bachelor of Science - Physics

University of Madras

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