Senior Embedded Software Engineer

Job Title: Senior Embedded Software Engineer (Medical Devices)

Location: ~15 miles North of Boston, MA (3 Days Onsite, 2 Day WFH)

Employment Type: Full-Time, Direct Hire (W2 Only - No Relocation, Locals Only)

Salary Range: Salary + 10-15% Bonus

Interview Process: Virtual (Microsoft Teams) followed by Onsite Interview

Visa Status: US Citizens or Green Card Holders only (No sponsorship available)

Job Summary:


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 .