Senior Software Engineer
(a) Design and implement robust, real-time embedded firmware in C/C++ for medical-grade hardware platforms.
(b) Develop low-level drivers, BSPs, and middleware for microcontrollers (ARM Cortex-M, RISC-V, etc.) and DSPs.
(c) Architect and integrate RTOS-based systems (FreeRTOS, Zephyr, VxWorks, or equivalent).
(d) Define and implement hardware abstraction layers (HAL) and device interface protocols (SPI, I2C, UART, USB, CAN).
(e) Conduct rigorous code reviews and ensure adherence to MISRA C/C++ coding standards.
(f) Medical Device Compliance & Quality
(g) Develop and maintain software documentation per IEC 62304 (Software Development Lifecycle for Medical Devices).
(h) Contribute to risk management activities in line with ISO 14971.
(i) Participate in FDA 510(k), CE marking, and other regulatory submission processes.
(j) Define and execute software verification & validation (V&V) plans, test protocols, and traceability matrices.
(k) Work closely with quality assurance teams to ensure compliance with GMP, MDR, and ISO 13485 standards.
(l) Technical Leadership & Collaboration
(m) Lead architectural discussions and technical design reviews within cross-functional teams.
(n) Mentor and coach junior and mid-level engineers in best practices for embedded development.
(o) Collaborate with hardware engineers, clinical scientists, quality and regulatory affairs on system-level requirements.
(p) Drive continuous improvement of development processes, toolchains, and CI/CD pipelines.
(q) Evaluate and integrate third-party components and open-source libraries with due diligence.