Sandeep H U

Led software architecture and development efforts for a hematology-based medical device under a regulated New Product Development (NPD) cycle. Collaborated across engineering, quality, and clinical teams to deliver a reliable, compliant, and high-quality diagnostic product in alignment with international medical standards.

Key Responsibilities:

• Spearheaded the end-to-end software architecture and design in compliance with IEC 62304 for Class B/C medical devices.
• Directed software design and development activities, translating clinical and system requirements into scalable software solutions.
• Acted as Cross-Functional Technical Lead, interfacing with hardware, firmware, QA/RA, and manufacturing teams to ensure seamless integration and delivery.
• Played a pivotal role in Risk Management (ISO 14971) – identifying, evaluating, and mitigating software-related hazards throughout the lifecycle.
• Conducted code reviews, enforced coding standards, and guided the team on best practices for safety-critical software.
• Initiated and developed Standard Operating Procedures (SOPs) aligned with internal QMS and regulatory compliance frameworks.
• Drove Configuration Management strategy for software assets, including branching, versioning, and release workflows.
• Participated in and facilitated Change Control Board (CCB) meetings, evaluating impact and traceability of proposed changes.
• Engaged in customer interactions for requirement gathering, feedback incorporation, and product demonstrations.
• Contributed to Usability and Reliability Engineering, working closely with design validation and human factors teams.
• Designed and implemented CI/CD pipelines and automated integration test plans to ensure consistent quality and early defect detection.
• Defined and reviewed test plans, ensured traceability to requirements, and supported regulatory documentation for verification and validation (V&V).

Software Architect | Scrum Master | Project Manager | Cross-Functional Lead | Customer Liaison

Key Contributions:

• Performed detailed requirement analysis and translated system needs into scalable, modular software architecture.
• Administered and maintained Azure DevOps environment, including user roles, boards, and automation tools.
• Managed code repositories, ensuring version control best practices, secure branching strategies, and traceability.
• Defined and implemented software development processes, aligned with industry standards and quality systems.
• Designed and developed frameworks to standardize architecture and accelerate development across multiple modules.
• Built and maintained CI/CD pipelines, automating builds, tests, and deployment workflows to improve release velocity.
• Acted as cross-functional team lead, coordinating efforts across development, testing, systems, and quality assurance teams.
• Served as the primary customer liaison, gathering feedback, aligning deliverables with expectations, and supporting demo and validation cycles.
• Led code reviews and identified performance bottlenecks, implementing strategies for optimization and scalability.
• Developed KPI tracking guidelines for productivity, quality, and delivery metrics aligned with project objectives.
• Oversaw integration activities and managed system reliability, ensuring robust end-to-end functionality across components.

• Defined functional specifications based on user requirements and system-level needs.
• Performed defect fixing and implemented application enhancements to improve performance and usability.
• Designed and developed automated test cases for validating software functionality and reliability.
• Conducted instrument troubleshooting to diagnose issues across hardware-software integration layers.
• Contributed to the development of project-specific tools and frameworks to accelerate testing and development.
• Managed product integration, including build creation, release packaging, and preparation of associated documentation.
• Provided mentorship and peer reviews, ensuring quality and consistency across team deliverables.
• Executed regression testing and comprehensive end-to-end integration testing across system components.
• Estimated efforts and planned activities for sprint tasks in line with Agile methodology.
• Collaborated with developers and QA engineers to analyze requirements and validate test coverage.

• Designed and developed software modules aligned with functional and system requirements.
• Performed debugging, fine-tuning, and performance optimization to enhance system throughput and responsiveness.
• Coordinated with team members for code integration, ensuring smooth collaboration across components.
• Conducted developer testing, unit testing, and integration testing to validate software functionality and quality.
• Developed basic simulators to emulate communication with the main application during development and testing.
• Refactored existing software components to improve code quality, maintainability, and modularity.
• Built internal verification tools to test software implementations and reduce manual validation effort.
• Participated in Agile development, contributing to the creation and refinement of user stories.
• Improved instrument throughput and processing efficiency through software optimizations.

• Designed and developed software modules based on functional and system requirements.
• Performed application fine-tuning and performance optimization to enhance system responsiveness and throughput.
• Coordinated with cross-functional team members to ensure smooth code integration and collaborative development.
• Executed developer testing, unit testing, and integration testing to ensure quality and stability.
• Maintained basic simulators for interfacing with the main application during development and testing.
• Participated in Agile ceremonies including story creation and refinement, sprint planning, and retrospectives.
• Conducted refactoring of software components to improve maintainability and compliance with design principles.
• Developed internal tools and utilities to verify implementation accuracy and streamline development workflows.
• Worked on improving the instrument’s operational throughput and performance metrics.

• Developed cross-platform proof-of-concepts using Qt and .NET for the modernization of the platform.
• Designed and implemented report generation features compliant with Client Specification.
• Conducted feasibility and interoperability analysis for integrating multiple systems and device protocols.
• Proposed and implemented cross-platform communication strategies to unify desktop and mobile operations.
• Implemented serial communication protocols to interface with infusion pumps and test devices.
• Developed multi-threaded communication architecture to manage simultaneous device interactions.

• Participated in smoke testing and validation for software stability and performance assurance.
• Resolved field-reported issues and performed ongoing maintenance and bug fixing.
• Contributed to requirements analysis, ensuring alignment with customer and regulatory needs.