Description

We are seeking an experienced Senior Embedded Software Engineer with 8–15 years of hands-on experience in embedded C/C++ development for Class II/III medical devices. This role involves the full software development lifecycle in FDA-regulated environments and requires close collaboration with cross-functional teams, including systems, hardware, and quality engineering. Ideal candidates will have a deep understanding of real-time operating systems (RTOS), regulatory standards, and a passion for innovation in the medical technology sector.

Key Responsibilities:

Design, develop, test, and document embedded software for medical devices, primarily in C/C++.

Develop on RTOS-based platforms, optimizing for performance, reliability, and safety.

Contribute to architecture, requirements analysis, software design, and risk assessments.

Ensure compliance with FDA regulations and medical device software development standards (IEC 62304, ISO 13485, etc.).

Collaborate with hardware engineers, QA, systems engineers, and regulatory teams throughout the development lifecycle.

Support verification and validation activities including unit testing and integration testing.

Participate in code reviews, debugging, and performance tuning of software.

Maintain detailed software documentation in accordance with internal SOPs and regulatory requirements.

Required Qualifications:

8–15 years of experience in embedded software development using C and C++.

Experience developing software for Class II/III FDA-regulated medical devices.

Strong background in real-time operating systems (RTOS).

Proven knowledge of the medical device development lifecycle and documentation standards.

Familiarity with hardware interfaces (I2C, SPI, UART, CAN, USB, etc.).

Strong understanding of software risk analysis, FMEA, and design for safety-critical systems.

Excellent problem-solving, communication, and cross-functional collaboration skills.

Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, or related field.

Preferred Qualifications:

Experience with Bluetooth, BLE, wireless communication, or battery-powered devices.

Exposure to unit testing frameworks, automated testing, and static code analysis tools.

Familiarity with Python, shell scripting, or other auxiliary languages for test automation.

Experience working in Agile or hybrid SDLC environments

Education

Any Gradute