Software Engineer

Job Overview
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.

Responsibilities
● 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.

Qualifications
● 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.

Pay: $4.00-$5.00 per year

Work Location: In person