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Team Description:

As part of the Surgery & Robot Hardware Department, the Surgical Consumables Team is responsible for producing a wide range of critical mechanical devices that enable our life-changing surgical procedures. Balancing immediate needs with long-term scalability, we drive innovation with precisely engineered tools that ensure safety, reliability, and high-quality surgical execution.

Job Description and Responsibilities:

We're looking for a Manufacturing Engineer to help scale the manufacturing of consumables used in our robotic surgeries. These consumables include the Needle Cartridge (the end effector that inserts electrodes into the cortex) as well as other complex mechanical assemblies and surgical proxies, like the one being assembled here.

In this role, you will help expand our team's capabilities by supporting the build-out of a new manufacturing site in Texas while sustaining production at existing sites. You'll work hands-on to troubleshoot manufacturing issues, analyze data, improve processes, and design fixtures. You will collaborate closely with hardware designers, machinists, quality engineers, and the surgery team to ensure parts are built correctly, released on time, and delivered where they're needed. 

You will contribute to technical solutions for complex manufacturing problems and help design processes that scale as production ramps. This role is well suited to someone who enjoys working closely with hardware, learning how products move from development to production, and operating in a fast-paced environment. The Manufacturing Engineer will:

• Support day-to-day production to meet consumables demand across the company
• Provide manufacturability input as products move into more mature lifecycle stages
• Design, test, and implement production fixtures, tooling, workstations, and assembly aids
• Troubleshoot manufacturing issues, perform root cause analysis, and implement corrective actions
• Support quality control activities in compliance with Design Control requirements, cGMP, FDA regulations, and internal policies
• Generate and maintain manufacturing documentation, including work instructions, Device Master Records (DMRs), and Design History Files (DHFs)
• Conduct risk assessments and support mitigation efforts to ensure product safety and reliability
• Drive continuous improvement efforts focused on yield, throughput, and process robustness

Required Qualifications:

• Strong interest in manufacturing small, safety-critical assemblies where precision and quality are paramount
• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Biomedical Engineering, or a related field, or equivalent experience
• 1+ year of experience in manufacturing engineering or engineering design
• Experience in Solidworks (preferred), OnShape, Creo, or an equivalent CAD program
• Demonstrated ability to execute on hardware-focused projects
• Hands-on experience physically building hardware (machining, fabrication, soldering, assembly, prototyping, etc.); personal projects are a plus
• A genuine interest in manufacturing and passion for learning

Preferred Qualifications:

• Experience working in a manufacturing environment
• Familiarity with ISO 13485, FDA 21 CFR Part 820, or other regulated manufacturing standards
  

Additional Requirements and Competencies:

• This role will initially require frequent travel to Fremont, CA, which is expected to decrease over time