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Axoft · 1 week ago

Director, Medical Device Software & Systems Engineering

Cambridge, MA

Full-time

Onsite

Director/Executive

$165K/yr - $210K/yr

10+ years exp

Axoft is building the most advanced infrastructure for implantable brain-machine interfaces. 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.

ElectronicsHealth CareMedicalMedical DeviceNeuroscienceTherapeutics

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

Qualification

Software ArchitectureSystems EngineeringModel-Based Systems EngineeringProgramming LanguagesRegulatory ComplianceData HandlingCommunication SkillsProblem-Solving Skills

Required

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