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Manufacturing Engineer, Microfabrication Fremont

Neuralink

Neuralink Fremont CA United States

2 months ago

Team Description:

The Microfabrication Team within Brain Interfaces designs, manufactures and verifies the thin-film microelectrode array that records and relays neural signals to the body of the implant. The team operates at an in-house cleanroom facility in Fremont...

Job Responsibilities:

As a Manufacturing Engineer with the Microfabrication Team at Neuralink, you will be responsible for scaling up production of microelectrode arrays, collaborating with engineers and/or techs and cross-functional teams to optimize process efficiency and improve array quality and throughput. In addition, you will provide daily support on processes, materials/supplier management, and equipment for new and sustaining products. As such, you will be instrumental in ramping production and accelerating Neuralink’s progress. You will also:
• Analyze production processes and equipment and identify opportunities for quality improvement, higher throughput, labor efficiency and cost reduction. Design, procure and implement new production equipment and stations.
• Implement continuous improvement plan to increase yield and quality using scalable solutions.
• Understand manufacturing concepts like Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), Product/Process Failure Mode and Effects Analysis (FMEA), process validations, statistical process control and problem-solving methodologies.
• 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, CGMP, FDA, and other company policies.
• Generate and modify manufacturing process documentation such as work instructions, process parameter sheets, BOMs, FMEAs, DMR, and DHF documents, etc., maintained as per medical regulatory standards.
• Participate in the investigation and evaluation of process failures. Implement root cause corrective actions for manufacturing and quality upgrades to prevent re-occurrence.
• Keep a clean, organized, and thoroughly maintained workspace.

Key Qualifications:
• 3+ years of experience in process manufacturing and/or regulatory industry
• Bachelor’s degree or higher in engineering technical field, preferably manufacturing, industrial, mechanical, chemical, or biomedical
• Familiarity with manufacturing techniques for prototypes and production versions of products. Experience with solid 3-D modeling (such as SolidWorks)
• Ability to interpret, distill, and disseminate relevant technical information
• Strong analytical, problem solving and project management skills
• Resourceful, flexible, and adaptable; no task is too big or too small
• Meticulous attention to detail and organizational skills
• Excellent verbal and written communication
• Ability to work in a medical device regulatory environment
• Ability to thrive in a dynamic environment

Preferred Qualifications:
• Knowledge of and experience implementing various manufacturing processes such as machining, fabrication, finishing, soldering, etc.
• Experience with statistical analysis such as six sigma, and DOEs along with structured problem solving and design for manufacturability and assembly (DFMA)
• Experience with process validations (IQ/OQ/PQ
Fremont CA USA

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