Highlights

• Medical Device Software Life Cycle: Extensive experience navigating the complete software development life cycle (SDLC) for medical devices, adhering to stringent regulatory standards such as IEC 62304 (Medical device software – Software life cycle processes).

• Safety-Critical Systems: Expertise in designing, developing, and verifying safety-critical embedded software for medical applications, including hazard analysis, risk management (ISO 14971), and implementing redundancy/fail-safe mechanisms.

• Regulatory Compliance & Quality: Strong understanding and practical application of quality management system (QMS) requirements (e.g., ISO 13485), ensuring all software development documentation meets regulatory submission requirements (FDA, CE, etc.).

• Real-Time Operating Systems (RTOS): Proficient in implementing and optimizing software on various RTOS (e.g., FreeRTOS, QNX, or custom kernels) to ensure deterministic, high-performance real-time operation required by monitoring or therapeutic devices.

• Hardware Interfacing & Low-Level Control: Deep technical skills in developing low-level drivers and control algorithms for hardware components specific to medical devices, such as sensors, actuators (pumps, valves), displays, and communication modules.

• Data Security and Privacy: Experience implementing robust security features, including encryption and access controls, to ensure the integrity and privacy of patient data in compliance with regulations like HIPAA and GDPR.

• Connectivity and Interoperability: Skilled in implementing various communication protocols (e.g., Bluetooth LE, Wi-Fi, Ethernet) to enable device connectivity, remote monitoring, and integration with hospital information systems (HIS).

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