Embedded Software Engineer- Medical Device

Seeking an experienced Embedded Software Engineer to support new product development and commercialization activities for Class III medical devices. The role involves embedded software/firmware development, integration, verification & validation, risk management, design transfer, and compliance with IEC 62304, FDA regulations, and Design Control requirements.

Responsibilities

• Design, develop, test, and maintain embedded software/firmware for medical device products.
• Support new product development, commercialization, design transfer, and manufacturing readiness activities.
• Develop software requirements, architecture, design documentation, and traceability.
• Support software integration, V&V, unit testing, and system testing activities.
• Perform software risk analysis, hazard assessments, FMEA, and cybersecurity evaluations.
• Troubleshoot and debug embedded applications using C/C++ and RTOS platforms.
• Collaborate with hardware, systems, quality, regulatory, and manufacturing teams throughout the product lifecycle.
• Ensure compliance with IEC 62304, FDA regulations, SDLC, and Design Control processes.

Qualifications

• Bachelor’s degree in Electrical Engineering, Software Engineering, Computer Science, or related field.
• Experience supporting Class III medical device development in regulated environments.
• Strong knowledge of IEC 62304, FDA regulations, Design Controls, and SDLC processes.
• Proficiency in C/C++, RTOS, and embedded debugging tools.
• Experience with software risk management, cybersecurity, traceability, and V&V activities.

Required Skills

• Proficiency in C/C++.
• Experience with embedded debugging tools.

Preferred Skills

• Experience with software risk management.
• Knowledge of cybersecurity evaluations.