Software Verification & Validation Engineer

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 the Quality Team, where our mission is to ensure compliance with relevant regulatory standards by streamlining operations and enhancing efficiency through innovative process development. We are a group of industry-experienced professionals who utilize creative problem-solving to establish efficient systems for compliance. Our vision is to set internal quality standards that exceed FDA expectations. We seek a dynamic individual who thrives on continuous improvement and is passionate about implementing systems that drive compliance and optimize performance.

Job Description and Responsibilities:

As a Software Verification & Validation Engineer, you will play a critical role in upholding the integrity of our software systems within a highly-regulated medical device environment. This position involves overseeing validation activities to ensure software meets FDA requirements, including 21 CFR Part 11, 21 CFR Part 820 and SaMD/SiMD guidelines, while collaborating across teams to support the development of new software tools. Specifically, you will:

• Sustain software V&V activities ensuring ongoing compliance and performance
• Own the software V&V program, including development, revision, and maintenance of Standard Operating Procedures
• Serve as the subject matter expert on 21 CFR Part 11, 21 CFR Part 820, IEC 62304, and other SW Validation Standards for driving overall compliance with FDA guidelines
• Conduct design controls, code reviews, unit tests, creation and review of sBOMs, and related activities to verify software integrity per regulatory standards
• Act as a Quality liaison with core software teams for the development and validation of internal systems
• Develop and own SaMD/SiMD compliance for our devices, including clinical evaluation, analytical validation, and risk management
• Develop and execute validation protocols, test plans, scripts, and reports to document software performance, including integrated verification activities with limited supervision
• Develop an automated V&V process for SW back-end testing
• Perform software risk assessments and contribute to hazard mitigation strategies
• Support regulatory audits, inspections, and submissions with comprehensive documentation
• Validate and verify software utilized across various divisions, including custom and off-the-shelf software
• Apply knowledge of high-level programming languages to create new test protocols, debug existing ones, and resolve issues

Required Qualifications:

• Bachelor's degree in software engineering, computer science, biomedical engineering, or a related field
• 1+ years of experience in a regulated field performing software design, verification, or validation, preferably in the medical device or pharmaceutical industries
• Proficiency in validation tools, scripting (e.g., Python), and code review processes
• Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams

Preferred Qualifications:

• 3+ years in medical device software validation, with hands-on IEC 62304 lifecycle experience
• Familiarity with risk management standards like ISO 14971, as well as IEC 60601 and other relevant medical device standards
• Experience in post-market surveillance and software updates in regulated environments
• Expertise in SaMD compliance, including FDA guidance on clinical and analytical validation
• Hands-on experience with software development lifecycle methodologies, including Agile and SAFe
• Proficiency with defect tracking tools (e.g., Jira) and statistical software (e.g., Minitab)
• Experience with regulatory agencies and standards like 21 CFR 820, ISO 13485, and IEC 62304/82304