About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
Join our innovative Quality Engineering team, a dynamic collective of experts dedicated to maintaining the precision and efficacy of high-tech equipment in preclinical and manufacturing domains. Engage with the latest in biomedical devices, industrial instrumentation, and cutting-edge technologies. As pioneers who've crafted a robust equipment program from scratch, we champion creative problem-solving and strive to set industry benchmarks. Immerse yourself in a mission-critical role that propels safety and regulatory compliance to new heights, and become part of a collaborative force driving the future of biomedical quality.
Job Description and Responsibilities:
As a Validation Engineer at Neuralink, you will collaborate with engineering teams to validate critical processes and systems, including sterilization, cleaning, and manufacturing, as well as ensuring adherence to stringent regulatory standards such as GMP and ISO. In addition to this core responsibility, you will support the Quality Engineering team with equipment and software qualifications, routine calibrations, and maintenance, as well as other essential tasks to uphold manufacturing integrity and regulatory compliance.
Furthermore, you will be expected to:
- Develop and write system verification and validation test methods to evaluate product requirements and ensure regulatory compliance
- Assess changes to design or manufacturing processes and their impact on existing validations
- Develop real-time dashboards for defect tracking and implement process improvements
- Communicate clearly and effectively, translating regulatory requirements into action
- Have a clear understanding of how to apply risk assessments
- Improve process efficiency and develop automated systems
- Demonstrate knowledge of Quality Assurance, Process Validation, Design Controls, Risk Management, and Statistical Techniques
- Exercise independent judgment and apply solution-oriented thinking, problem-solving, and troubleshooting
Required Qualifications:
- Bachelor’s degree in an engineering discipline
- Minimum 2 years of experience in a medical device or life sciences organization
- Attention to detail: ability to perform critical analysis of situations and provide recommendations
- Capable of working independently with structured guidance
- Experience developing critical quality programs and systems
- Strong foundation in basic science and engineering principles
- Experience in regulatory environments (e.g., GMP, GCP, or GLP)
Preferred Qualifications:
- Familiarity with computer systems such as coordinate measuring systems, Jira, and CAD
- Experience designing test methods and test strategies, developing and executing validation protocols, analyzing and interpreting results, and communicating results and their impact through written reports, design reviews, and interactive discussions
- Experience in process validation, test method validation, gage R&R, experiment design, and troubleshooting manufacturing failures
Additional Requirements and Competencies:
- Ability to travel to/from and work in multiple locations
- Comfort working in office, vivarium, and operating room environments, with potential exposure to animal bodily fluids, including blood
- Basic computer skills and proficiency in Google Docs, Google Drive, Gmail, and Jira
- Ability to use equipment controllers and interfaces of varying degrees of complexity
Expected Compensation:
At Neuralink, your base pay is one part of your total compensation package. The anticipated base salary for this position is expected to be within the below range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.Texas Base Salary Range$65,000—$108,000 USD
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity + 401(k) plan *Temporary Employees & Interns excluded
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
