Embedded Software Engineer - Medical Devices

We are seeking a highly motivated and detail-oriented Embedded Software Engineer to join our development team. The ideal candidate will design, develop, and maintain embedded software for safety-critical medical devices in compliance with regulatory standards. This role requires strong technical expertise in embedded systems, real-time software development, and familiarity with medical device quality and regulatory frameworks.

Key Responsibilities

● Design, develop, test, and maintain embedded software for medical devices.

● Implement firmware for microcontrollers, processors, and embedded RTOS.

● Develop real-time, safety-critical software in compliance with IEC 62304 and other applicable standards.

● Participate in a full software development lifecycle (SDLC), including requirements analysis, architecture design, implementation, verification, validation, and maintenance.

● Generate and maintain software documentation per FDA, Health Canada, MDR, ISO 13485, and other regulatory requirements.

● Support risk management activities (ISO 14971), including DFMEA.

● Conduct unit testing, integration testing, and support system verification and validation activities.

● Perform code reviews and ensure adherence to coding standards.

● Investigate and resolve software defects and field issues.

● Participate in design reviews, audits, and regulatory submissions as required.

Required Qualifications

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

● 4+ years of experience in embedded software development (medical device experience preferred).

● Strong proficiency in C/C++ for embedded systems.

● Experience with RTOS or embedded Linux environments.

● Experience with microcontrollers (such as ARM Cortex, STM32, PIC, etc.).

● Familiarity with communication protocols (UART, SPI, I2C, CAN, USB).

● Understanding of software architecture and design patterns for embedded systems.

● Experience with debugging tools (JTAG, oscilloscope, logic analyzer, etc.).

● Familiarity with version control systems (Git, SVN).

● Strong problem-solving skills and attention to detail.

● Commitment to patient safety and product reliability.

Preferred Qualifications

● Experience in Graphic User Interface (GUI) design

● Experience in medical device development.

● Knowledge of IEC 62304 (Medical Device Software Lifecycle).

● Familiarity with ISO 13485 and ISO 14971.

● Experience developing Class II or Class III medical devices.

● Knowledge of cybersecurity requirements for medical devices.