Senior Technical Architect C#, .NET

Job Summary

Lead firmware architecture, design, development, and validation for complex medical device systems, ensuring compliance with regulatory standards (IEC 62304, FDA, MDR). Drive hardware–software integration, verification testing, and design control processes while providing technical leadership, cross-functional coordination, and timely delivery of high-quality, safe, and effective products.

Key Responsibilities

Define and deliver firmware architecture for medical device systems Develop, debug, and integrate embedded firmware and hardware Ensure compliance with IEC 62304, FDA, and design control guidelines Create and execute verification & validation (V&V) test protocols and reports Drive design inputs, risk analysis, and technical strategy Lead cross-functional collaboration and NPI execution Mentor engineers and enforce best practices in firmware development Manage stakeholders and ensure timely project delivery

Skill Requirements

Strong embedded firmware development in **C/C++**Experience with microcontrollers (ARM Cortex-M) and peripherals (SPI, I2C, UART, CAN)Knowledge of RTOS (FreeRTOS/Embedded Linux) and bare-metal systems Expertise in hardware–software integration and debugging

Understanding of analog/digital circuits and signal processing

Experience with medical device standards (IEC 62304, FDA, MDR, ISO)Hands-on in Verification & Validation (V&V)** and test protocol creation Familiarity with** design control, risk management, and quality processes

Exposure to tools like Altium, lab instruments (oscilloscope, etc.)Strong analytical, problem-solving, and communication skills

Other Requirements

7+ years in embedded/firmware development Medical device & regulatory experience Strong debugging & prototyping skills Experience in NPI & cross-functional teams Good communication and leadership skills Willingness for occasional travel