Team Description:

The Biocompatibility and Analytical Sciences Team is responsible for implementing and operating numerous tests, performing test-method validations, finalizing reports, and supporting R&D activities. We are a dedicated group of highly skilled professionals responsible for ensuring the accuracy, reliability, and compliance of analytical processes and methods used to improve and verify the quality and safety of our devices and facilities. With expertise in various analytical techniques, such as chemical characterization, microbiological testing, and cell-based assay, this team is crucial in maintaining product quality and safety.

Job Description and Responsibilities:

As a Microbiologist, you will work with teams across the Neuralink organization to evaluate biological characteristics of manufacturing processes and finished devices. This role involves various levels of product testing during R&D and release phases to obtain data that may be required for product approvals. Additionally, this data may be used to confirm product safety in accordance with applicable global regulations, regulatory guidelines, or voluntary consensus standards. The primary goal of this position is to assist in the biological characterization of medical devices to support patient safety and facilitate regulatory approval. Responsibilities will include:

• Drafting validations, internal procedures, and test protocols
• Conducting environmental and process monitoring
• Performing laboratory tasks including sample preparation, laboratory testing, method development, inventory management, and developing controls for analysis
• Implementing and operating microbial test methods such as aerobic organism quantitation, yeast/mold quantitation, and genomic identification
• Conducting routine and non-routine testing of materials and products to ensure compliance with quality standards and regulatory requirements; this includes performing calibration checks and maintaining documentation
• Validating and monitoring cleaning processes and water systems to ensure product cleanliness
• Managing and monitoring the environmental monitoring program to identify and eliminate potential contamination sources
• Delivering test results related to device biotic characteristics to support manufacturing changes and risk assessments
• Producing laboratory reports that comply with applicable medical device evaluation standards and FDA/ISO guidance documents within a risk-based framework
• Collaborating with cross-functional teams to support multiple projects requiring laboratory evaluation, ensuring timely completion of required tasks to meet project schedules
• Analyzing test results to determine data adequacy for internal and external requirements and utilizing problem-solving skills and technical knowledge to troubleshoot unexpected results
• Participating in continuous improvement projects to increase lab efficiency, reduce turnaround times, and improve data quality

Required Qualifications: 

• Bachelor of Science in Microbiology, Biology, Environmental Science, or a related field
• 1-2 years of experience in a microbiology laboratory
• Experience and knowledge of basic microbiology laboratory operations such as culturing, enumeration, and identification
• Ability to perform routine calculations for microbiological analysis and test method validation such as serial dilution, quadrant multiplication, accuracy, precision
• 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 microbiological processes for efficiency and compliance
• Problem-solving mindset
• Strong written and oral communication skills

Preferred Qualifications:

• Familiarity with Good Laboratory Practices, Good Manufacturing Practices, or relevant laboratory regulatory standards (e.g., ISO 17025)
• Experience auditing laboratory or manufacturing spaces
• Experience troubleshooting laboratory instrumentation and equipment
• Experience performing bioanalytical procedures and cell-based assays
• Experience with method validation and transfer