Embedded Software Engineer

Lexington Medical is a successful, growing venture-backed medical device company, manufacturing minimally invasive surgical stapling solutions. With the highest standards in design engineering and smart manufacturing, our team delivers healthcare providers with innovations that improve surgical outcomes for their patients in a thriving $5B+ Surgical Stapler market. We are looking for world-class multidisciplinary SW Engineering talent to join the team.

You will be responsible for contributing to the research and development of software solutions that drive innovation within our surgical stapling solutions. Our technological stack involves embedded device software, communication protocols, data driven analysis, image pipeline and front-end user interface application. The ideal candidate will have a strong background in software engineering, multidisciplinary capabilities, a deep understanding of medical device regulations, and a passion for creating high-quality, reliable, and secure software.

Responsibilities:

• Lead the design, development, testing and documentation of software solutions while ensuring compliance with industry standards and regulations.
• Collaborate with regulatory affairs teams to facilitate product approvals and compliance.
• Contribute to the design and architecture of software systems, ensuring scalability, maintainability, and compatibility with hardware components.
• Collaborate with system architects to define software interfaces and interactions.
• Collaborate with cross-functional teams, including hardware engineers and quality assurance, to deliver integrated and reliable systems.
• Ensure that software development processes and deliverables adhere to regulatory requirements, including FDA guidelines for medical device software.
• Facilitate knowledge transfer and ensure documentation compliance with regulatory standards.
• Collaborate with interdisciplinary teams, including engineers, and regulatory SMEs to achieve project goals.

Requirements:

• Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field.
• 2+ years of related experience with a core focus on embedded systems
• Strong proficiency in programming languages such as C, C++, .Net C#, or Python.
• Experience with embedded systems, and software-hardware integration.
• Experience with version control systems (e.g. Git) and issue tracking tools.
• Familiarity with agile development methodologies.
• Experience in the medical device industry with familiarity with regulatory frameworks for medical device software, including FDA guidelines, is preferred.