• Location: Cambridge, MA

• Department: Product Development

• 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 an experienced systems engineer to lead systems engineering activities for the development of Axoft’s neural interface platforms. This is a senior technical role focused on systems engineering. The ideal candidate will provide technical leadership, mentor junior engineers, and drive the development systems for Axoft’s first and subsequent medical device products, ensuring scalability, security, and regulatory compliance.

Key Responsibilities

• Systems Engineering

  • 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, verification/validation, and trade-off analysis processes for complex systems.

  • Serve as the technical owner of the system architecture and represent the overall system in design reviews.

• Compliance & Quality

  • Ensure adherence to medical device regulatory requirements and use the system model to produce robust documentation for regulatory submission.

  • Champion best practices in systems thinking, MBSE, and documentation.

• 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 define and maintain system interfaces.

What Success Looks Like

• A complete, auditable system model supporting design, risk management, and regulatory submission.

• Clearly defined system interfaces across hardware, firmware, software, and cloud.

• Traceability from user needs through verification for Axoft’s first clinical product.

• Reduced rework and integration risk through early system-level modeling.

• Scalability across Axoft’s intended product platform.

Qualifications

• Education:

  • Bachelor’s or Master’s degree in engineering or another highly technical field (e.g., computer science).

• Experience:

  • 5+ years in systems engineering for Class II or Class III medical devices.

  • Expertise collaborating with multifunctional engineering teams.

  • Hands-on experience with MBSE methodologies and SysML modeling tools (Cameo is a plus).

  • Ownership of system models in previous projects.

• Skills:

  • Systems thinking and familiarity with mechanical, electrical, software, human factors, and other technical domains.

  • Strong knowledge of SysML and MBSE best practices.

  • Ability to manage requirements, risk, and traceability for a hardware/embedded/application/cloud platform.

  • Excellent technical writing skills and ability to produce clear, unambiguous documentation.

  • 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.