Senior Embedded Software Engineer
1 day ago
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.
- 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.
- 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.
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