Compensation Overview

Team Description:

The Surgery & Robotics Engineering Team tackles challenges across surgical robotics, such as creating next-gen hardware to drive total brain surgery time down from hours to seconds; designing laser-micromachining for micron-precision geometries for surgical end effectors; developing ways to reach deeper brain targets while balancing the competing goals of endpoint accuracy and minimally invasive insertion; and scaling from hundreds to millions of surgeries.

Job Description and Responsibilities:

We’re looking for a Manufacturing Engineer who will lead a team of technicians to build and scale the manufacturing of the consumables used in our robotic surgeries, including the Needle Cartridge, the end effector of the robot that inserts the electrodes into the cortex.  

In this role, you will own day-to-day production planning and fulfillment of the robot and surgery consumables. You will initially lead a small team of technicians and production engineers and eventually build out the team further as the company scales. You will act as the interface to engineering, quality, and other manufacturing departments across Neuralink as the responsible person for robot and surgery consumables manufacturing. You will own technical solutions to complex manufacturing problems and design processes to scale the production line as it ramps up.

The right person for this role can demonstrate a history of owning and solving challenging manufacturing problems in a fast-paced, resource-limited environment. If you are someone who thrives in such an environment, then this role is for you. 

• Manage a production team to keep up with current demand for consumables across the company
• Work with design engineers and give technical feedback on designs to scale production by 100x in the next few years
• Provide manufacturability input to engineers during the process development process as product moves to mature stages of its lifecycle while ensuring compliance to Design Control requirements, Current Good Manufacturing Practices, FDA, and other company policies.
• Design, test, and implement new production fixtures, toolings, stations, and other components of assembly lines
• Develop and implement quality control protocols based on ISO 13485 and FDA regulations
• Generate and maintain comprehensive documentation, including Device Master Records (DMR) and Design History Files (DHF)
• Collaborate with supply chain and shipping and receiving teams to improve inventory management systems
• Investigate and resolve manufacturing issues promptly by working with design engineers or personally owning technical solutions
• Conduct risk assessments and implement mitigation strategies to ensure product safety and reliability
• Conduct root cause analysis for deviations and implement continuous improvement initiatives

Required Qualifications:

• Bachelor’s of Science (B.S) degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or a related field or equivalent experience
• Experience in Solidworks, OnShape, Creo, or an equivalent CAD program
• 3+ years of experience in manufacturing (or design) of complex mechanical systems or similar, inclusive of operating the manufacturing floor in some capacity
• Demonstrated ability to creatively deliver hardware in a resource-constrained environment
• Demonstrated direct team leadership skills inclusive of hiring and personnel management, with backing examples
• Personal experience physically manufacturing hardware via any means (machining, fabrication, soldering, assembly, etc.); work on personal projects is a plus
• A genuine interest in manufacturing and passion for learning
• Strong operational background inclusive of items such as optimizing processes, optimizing labor inputs, and scheduling production to meet volatile demand

Preferred Qualifications:

• ISO 13485 or equivalent medical device manufacturing familiarity
• Familiarity with FDA 21 CFR Part 820 and other applicable standards