Validation Engineer

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 various processes and systems, such as sterilization, cleaning, software, and manufacturing. In addition to this primary responsibility, you will assist the Quality Engineering team with equipment and software qualifications, routine calibrations and maintenance, and other tasks to support manufacturing and compliance. Furthermore, you will be expected to:

• Develop and write system verification and validation test methods to evaluate product requirements
• 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