Description

Design, develop, and document embedded software for Class II/III medical devices within FDA-regulated environments.

This role is on-site.

Responsibilities

• Design and develop embedded software using C/C++ on RTOS-based platforms.
• Contribute to software architecture, requirements analysis, and risk assessments.
• Ensure compliance with IEC 62304, ISO 13485, and FDA regulatory standards.
• Collaborate with hardware, systems, and quality engineering teams throughout the lifecycle.
• Support verification and validation through unit testing, integration testing, and debugging.

Required Skills

• 8–15 years of hands-on experience in embedded C/C++ development.
• Direct experience developing software for Class II/III FDA-regulated medical devices.
• Deep understanding of Real-Time Operating Systems (RTOS).
• Knowledge of hardware interfaces including I2C, SPI, UART, CAN, and USB.
• Experience with software risk analysis, FMEA, and safety-critical system design.
• Bachelor’s or Master’s degree in Electrical Engineering, Computer Engineering, or a related field.

Preferred Skills

• Experience with Bluetooth, BLE, wireless communication, or battery-powered devices.
• Familiarity with Python, shell scripting, and automated testing tools.
• Experience working in Agile or hybrid SDLC environments.

Key Skills

Education

Any Gradute