Lead Embedded Software Engineer – Medical Devices (ISO 62304)

Cutera-Inc; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Cutera-Inc in Raleigh, NC seeks a Principal Embedded Software Engineer to lead the design and development of embedded software for medical devices, ensuring safety, performance, and regulatory compliance.

You will translate system requirements into robust software, collaborate with hardware, systems, and quality teams, and drive V&V, design control, and lifecycle activities from concept to sustaining engineering.

Qualifications

• Bachelor’s or Master’s degree in Electrical Engineering, Computer Science, or related field with 12+ years of embedded software experience.
• Deep expertise in embedded systems with microprocessor-based controllers and fault finding.
• Proficient in C and C++ for embedded applications.
• Experience with RTOS and bare-metal development.
• Familiarity with ISO 14971 risk management and design control practices.
• Experience working in cross-functional teams including hardware, systems, quality, and manufacturing engineering.

Responsibilities

• Lead embedded software development activities across the full medical device lifecycle in accordance with ISO 62304.
• Collaborate with hardware, systems, and quality engineering teams to define system architecture, software requirements, and design specifications.
• Design, develop, and maintain embedded software primarily in C and C++ for microcontroller and processor-based systems.
• Participate in requirements definition, risk analysis, and traceability to ensure compliance with regulatory standards.
• Develop and execute software verification and validation activities, including unit testing, integration testing, and system-level testing.
• Support design reviews and ensure adherence to design control processes.
• Contribute to software documentation, including requirements, architecture, design, and test artifacts.
• Support new product introduction (NPI), design transfer, and sustaining engineering activities.
• Troubleshoot and resolve software defects across development and production environments.
• Ensure compliance with applicable regulatory and quality standards through structured development and documentation practices.

Skills

Embedded systems

Regulatory compliance

Risk analysis

Documentation

Cross-functional teamwork

Debugging

Verification & Validation

Version control

RTOS/Bare-metal

Schematic reading

Education

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

Tools

C

C++

RTOS

Embedded toolchains

Git

Job description

Cutera-Inc in Raleigh, NC seeks a Principal Embedded Software Engineer to lead the design and development of embedded software for medical devices, ensuring safety, performance, and regulatory compliance.

You will translate system requirements into robust software, collaborate with hardware, systems, and quality teams, and drive V&V, design control, and lifecycle activities from concept to sustaining engineering.