Embedded Software Engineer - Medical Devices

Job Title: Embedded Software Engineer – Medical Devices

Pay rate: Open for discussion

Duration: 06 months (temp to hire)

W2 contract only (No C2C)

Location- Raleigh, NC

We are seeking an experienced Embedded Software Engineer to join our medical device development team. The ideal candidate will have a strong background in embedded systems programming, coupled with hands-on experience in the design, development, and testing of FDA-regulated medical devices. You’ll work closely with cross-functional teams including hardware, quality, and regulatory to develop safe, effective, and innovative medical products.

Key Responsibilities:

Design, develop, and test embedded software for Class II/III medical devices in compliance with FDA and ISO standards.

Collaborate with hardware engineers to define software/hardware interfaces and integration strategies.

Develop software for real-time systems using C/C++ on embedded platforms (e.g., ARM Cortex, TI MSP430, etc.).

Implement communication protocols (UART, SPI, I2C, BLE, USB).

Participate in risk analysis, software requirements, design reviews, and code inspections.

Create and maintain documentation including software requirements, design specifications, verification protocols, and test reports.

Perform unit testing, integration testing, and support system-level validation.

Ensure compliance with IEC 62304, ISO 14971, and other regulatory requirements.

Support root cause analysis and software updates for field issues or design improvements.

Qualifications:

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

5+ years of experience in embedded software development, with at least 1–2 years in medical device industry.

Proficiency in C/C++ programming for microcontrollers or embedded Linux platforms.

Strong knowledge of real-time operating systems (RTOS) and low-level device drivers.

Experience with regulatory standards: IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820.

Experience with debugging tools, oscilloscopes, and protocol analyzers.

Strong problem-solving and communication skills.

Preferred Skills:

Familiarity with Bluetooth Low Energy (BLE), Wi-Fi, or other wireless communication protocols.

Experience with scripting languages (Python, Bash) for test automation.

Exposure to cybersecurity standards for connected medical devices (e.g., FDA premarket guidance, ISO/IEC 27001).

Experience with Agile or Scrum development methodologies.

Important information: To be immediately considered, please send an updated version of your resume to .