Director, Medical Device Software Engineering at Axoft

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Jun, 26

Salary

210000.0

Posted On

15 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Architecture, Embedded Systems, Real-Time Operating Systems, C/C++, Python, Scalability, Security, IEC 62304, ISO 13485, FDA Regulatory Requirements, Cybersecurity, Data Pipelines, ML Models, IOT Protocols, Technical Leadership, Mentorship

Industry

Software Development

Description

Location: Cambridge, MA Department: Software Reports To: VP of Product Development Summary 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 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. 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. Key Responsibilities Software Architecture & Development (80% Architecture, 20% Development) 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. Compliance & Quality 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. Technical Leadership & Mentorship 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. Qualifications Education Bachelor’s or Master’s degree in computer science, electrical engineering, or related field. Experience 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. Skills 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. What we offer An opportunity to work with a team of experts on one of the most exciting problems in the world and change lives. Career growth opportunities that fit your potential. Comprehensive benefits plan including health and dental insurance; parental leave. Flexible paid time off. Axoft’s ideal team members are people who seek fast-paced, evolving work with bright, thoughtful, and dedicated teammates. We seek and embrace challenges, and we are ultimately focused on improving the health and well-being of people. We believe in producing the highest quality work, and we hold ourselves and each other to high standards of integrity, accountability, growth, and trust. Axoft provides equal opportunity in all our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Responsibilities

The Director will serve as the principal software architect, defining the architecture for embedded and/or application components, establishing design patterns, and leading the team in developing real-time embedded software, data pipelines, and user-facing applications for the medical device product. This role also requires ensuring adherence to critical regulatory standards like IEC 62304 and ISO 13485 for medical device software.