Director, Medical Device Software & Systems Engineering

Axoft • Cambridge, MA

3d • Onsite

About The Position

Axoft is building the most advanced infrastructure for implantable brain-machine interfaces. Our mission is to enable long-term stable and ultra-high bandwidth communication with the brain, opening new therapies and treatments against neurological disorders and physical disabilities. We have bridged the gap between electronic and biological materials to create the softest, nanofabricated brain implants in the world. Position Overview We are seeking a highly experienced Director of Software & Systems Engineering to lead the architecture and integration of the software for Axoft’s neural interface platforms. This is a senior technical role focused on software architecture and systems engineering. The ideal candidate will provide technical leadership, mentor junior engineers, and drive the development of software and systems for Axoft’s first medical device product, ensuring scalability, security, and regulatory compliance. Our ideal candidate is responsible for both software and systems engineering. Please apply if you are exceptional at either domain. We are willing to split the role for the right candidate.

Requirements

• Bachelor’s or Master’s degree in computer science, electrical engineering, systems engineering, or related field.
• 10+ years in software and systems engineering, with significant experience in software architecture for complex, safety-critical systems (medical devices, aerospace, or similar regulated industries).
• Expertise leading multifunctional software teams including embedded systems, real-time operating systems, deployed ML models, and IOT protocols.
• Hands-on experience with MBSE methodologies and SysML modeling tools; ownership of system models in previous projects.
• Strong knowledge of programming languages (C/C++, Python, etc.) and modern software development practices.
• Familiarity with large data handling
• Familiarity with regulatory frameworks (FDA, CE marking) and quality systems.
• Excellent communication and problem-solving abilities; ability to influence technical decisions across teams.

Responsibilities

• Serve as the principal software architect, defining architecture for embedded and/or application components.
• Establish design patterns, frameworks, and technology stack decisions to ensure scalability, reliability, and security.
• Lead the team, and contribute to, developing real-time embedded software, data pipelines, and user-facing applications for Axoft’s first medical device product.
• Own system-level design, including hardware-software integration and interoperability across platforms.
• Lead Model-Based Systems Engineering (MBSE) activities using SysML and own the system model, ensuring traceability from requirements through design and verification.
• Drive requirements definition, risk analysis, and verification/validation processes for complex systems.
• Ensure adherence to IEC 62304, ISO 13485, and FDA regulatory requirements for medical device software.
• Champion best practices in software development, cybersecurity, and quality assurance.
• Act as a subject matter expert and mentor for junior engineers, fostering technical growth and knowledge sharing.
• Collaborate closely with cross-functional teams (hardware, product, clinical) to deliver integrated solutions.

Benefits

• An opportunity to work with a team of experts on one of the most exciting problems in the word and change lives.
• Career growth opportunities that fit your potential.
• Comprehensive benefits plan including health and dental insurance; parental leave.
• Flexible paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 251-500 employees