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.
What We Do
Lexington Medical is singularly focused on making the best surgical stapler in the world. A high-growth, ambitious Boston-based medical device manufacturer with exacting technical and talent standards, Lexington develops advanced engineering and smart manufacturing in-house to deliver disruptive innovation. We are proud to provide surgeons a better choice in surgical stapling.
Our AEON Endostapler offers industry-best clinical performance across a wide range of surgical specialties. Working closely with leading physicians, our design approach allows us to be nimble and responsive to deliver a continuously improving product.
WE’RE HIRING! We have vigilantly cultivated a team of the most talented, collaborative, and creative people and are always looking to add teammates to our high-performance environment. Our employees at all levels manage projects that have a direct impact on patient care. If you are inspired to join a company that is solving problems that others have said “can’t be solved,” please visit us at www.lexington-med.com/careers.
