Team Description:

You will be part of the Quality Control team responsible for running multiple tests in-house, performing test method validations, finalizing reports, and supporting R&D activities. The QC Team is a dedicated group of highly skilled professionals responsible for ensuring the accuracy, reliability, and compliance of test methods used in the quality control process. With expertise in various analytical techniques, such as chemical characterization, microbiological testing, and biocompatibility evaluations, this team is crucial in maintaining product quality and safety.

Job Description and Responsibilities:

The Analytical Technician will work with teams across the Neuralink organization to analyze the chemical and biological characteristics of manufacturing processes and finished devices. This will include various levels of product testing during R&D and release to obtain data that may be required for product approvals. Additionally, this data may be used to confirm patient safety of our products by applicable global regulations, regulatory guidelines, or voluntary consensus standards. Daily responsibilities may involve drafting internal procedures and test protocols, sample preparation, laboratory testing, method development, inventory management, and other miscellaneous laboratory tasks. The Analytical Laboratory Technician’s primary goal will be to assist in medical device chemical and biological characterization to support patient safety and regulatory approval. 

• Prepare test samples and controls for analysis.
• Perform chromatographic and mass spectrographic analysis using a variety of instruments such as LC-MS, GC-MS, and ICP-MS.
• Conduct routine and non-routine testing of materials and products to ensure compliance with the quality standards and regulatory requirements, including performing calibration checks and maintaining documentation.
• Deliver test results related to device analytical characteristics to support manufacturing changes and risk assessments. 
• Deliver laboratory reports complying with applicable medical device evaluation standards and FDA/ISO guidance documents within a risk-based framework.
• Collaborate with a cross-functional team to support multiple projects requiring laboratory evaluation, ensuring timely completion of required tasks to meet project schedules.
• Analyze test results to determine the adequacy of data to meet internal and external requirements and utilize problem-solving skills and technical knowledge to troubleshoot unexpected results.
• Participate in continuous improvement projects to increase lab efficiency, reduce turnaround times, and improve data quality. 

Required Qualifications:

• Bachelor’s Degree in Chemistry
• 1-2 years of experience in an analytical laboratory
• Possess experience and knowledge of basic laboratory operations such as weighing, sample handling, and preparing volumetric solutions.
• Able to perform routine calculations about analytical chemistry (e.g., dilution, concentration, results calculation)
• A basic understanding of laboratory safety and the use of engineering controls such as fume hoods and biological safety cabinets
• Demonstrated ability to develop and optimize analytical processes for efficiency and compliance
• Problem-solving mindset
• Strong written and oral communication skills

Preferred Qualifications:

• M.S. in Chemistry, Biochemistry, or a related field
• Familiarity with Good Laboratory Practices and/or Good Manufacturing Practices
• Experience with LC-MS, GC-MS, and ICP-MS
• Familiarity with chromatography data systems
• Experience with troubleshooting analytical instrumentation
• Experience performing bioanalytical procedures and cell-based assays
• Experience with method validation and transfer