Lexington Medical, Inc. is developing and manufacturing minimally invasive surgical stapling solutions and needs to design, develop, and integrate embedded systems within their advanced surgical stapling platform.
Requirements
- 5+ years of embedded software development experience, preferably within regulated or safety-critical industries (medical devices highly preferred).
- Strong proficiency in C/C++ for embedded systems; experience with Python or C-Sharp is a plus.
- Familiarity with real-time operating systems (RTOS), firmware development workflows, and embedded debugging tools.
- Demonstrated ability to integrate hardware and software for complex electro-mechanical products.
- Working knowledge of version control systems (Git) and issue tracking tools (JIRA).
- Deep understanding of software quality systems, documentation control, and risk management per IEC 62304 and ISO 13485.
- Establish and uphold software development standards, documentation practices, and verification processes in accordance with IEC 62304 and FDA Class II/III medical device guidelines.
Responsibilities
- Define and implement embedded software architecture for Lexington's surgical stapling platform and supporting devices.
- Architect, design, and implement real-time embedded software for microcontroller-based systems (ARM Cortex-M or equivalent).
- Develop and integrate low-level drivers, communication interfaces (SPI, I²C, CAN, UART, USB), and application-layer logic.
- Ensure scalability, maintainability, and hardware compatibility through modular software design.
- Drive continuous improvement of firmware quality, codebase maintainability, and traceability.
- Partner with electrical, mechanical, and systems engineers to ensure seamless integration of hardware and software.
- Support product verification and validation activities, contributing to system testing and documentation.
Other
- Proven experience leading or mentoring engineers in a hands-on technical environment.
- Collaborate with management to identify capability gaps, staffing needs, and training opportunities to build a high-performing embedded team.
- Work closely with regulatory, quality, and manufacturing teams to maintain compliance and support product submissions.
- Manage technical deliverables, timelines, and documentation for embedded software projects.
- Excellent analytical, communication, and cross-functional collaboration skills.
