• Location: Cambridge, MA

• Department: Engineering

• Reports To: Director of Hardware

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

As a Mechanical Engineer at Axoft, you will design mechanical systems and integrate them with electronics to produce implantable neural interfaces. This role combines mechanical packaging, thermal management, and reliability engineering to deliver robust, compliant hardware platforms. You will collaborate with electrical engineers, neuroscientists, microfabrication engineers, and clinical teams to ensure seamless integration and performance under strict medical device standards.

Core Responsibilities

• Design, prototype, test, and implement mechanical solutions for implant packaging, housing, assembly, and surgical implantation.

• Develop mechanical components ensuring biocompatibility and compliance with ISO 10993 and IEC 60601 standards.

• Perform thermal and structural analysis for implantable systems under physiological conditions.

• Collaborate with microfabrication and neuroscience teams to optimize implant integration.

• Create and maintain engineering documentation, CAD models, and design history records in alignment with QMS.

• Support manufacturing processes (DFM/DFA) and reliability testing for implantable components and implantation tools.

• Develop automated test setups for mechanical validation.

• Ensure compliance with mechanical tolerances and reliability requirements.

• Mentor junior engineers and contribute to cross-functional design reviews.

Key Competencies for Success

• Technical Expertise: Strong knowledge of mechanical design principles, and thermal management, and materials science.

• Tools & Implementation: Proficiency in at least one 3D CAD program for mechanical design.

• Problem-Solving: Ability to innovate under strict size, power, and biocompatibility constraints.

• Collaboration: Comfortable working in multidisciplinary teams and communicating effectively.

• Regulatory Awareness: Familiarity with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, and ISO 10993 biocompatibility standards.

• Leadership Potential: Ability to guide projects and mentor team members.

Required Qualifications

• Education: B.S./M.S. in Mechanical Engineering, Biomedical Engineering, or related field

• Experience: 3+ years in mechanical design for hardware systems

• Required Skills/Qualifications: Mastery of 3D CAD and mechanical drawings (GD&T, tolerance analysis), experience with mechanical packaging of electronics, design-controlled environments (e.g., ISO 13485), design for manufacture and assembly (DFM/DFA), strong understanding of engineering first principles.

Preferred Qualifications

• Education: M.S. or Ph.D. in relevant disciplines.

• Experience: 5+ years in Class II or class III implantable medical devices

• Preferred Skills/Qualifications: FEA analysis (e.g., strain/stress, thermal); experience with implantable or wearable medical devices, experience with surgical tools, knowledge of biocompatibility standards; knowledge of sterilization methods and material compatibility; hands-on rapid prototyping, fixture design, experience with injection molding and CNC machining (via CMO or firsthand), experience in metrology and statistical tolerance analysis, and experience working with or managing contract manufacturers

Career Development Path

• Progression to Senior Mechanical Engineer based on performance and leadership impact.

Internal Mobility Considerations

• Ideal candidates should demonstrate technical depth, leadership potential, and ability to collaborate across engineering and clinical teams.