Neuralink · 2 hours ago
Software Verification & Validation Engineer
Austin, TX
Full-time
Onsite
Entry, Mid Level
$71K/yr - $119K/yr
1+ years expNeuralink is creating devices that enable a bi-directional interface with the brain, aiming to restore movement and sight while revolutionizing human interaction with technology. The Software Verification & Validation Engineer will ensure software compliance with FDA regulations, overseeing validation activities and collaborating across teams to support software tool development.
BiotechnologyMedicalNeuroscienceRobotics
Responsibilities
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
Qualification
Required
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
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
Benefits
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 (RSUs) Temporary Employees & Interns excluded
401(k) plan Interns initially excluded until they work 1,000 hours
Parental leave Temporary Employees & Interns excluded
Flexible time off Temporary Employees & Interns excluded
Company
Neuralink
Neuralink is a neurotechnology company that focuses on developing brain-computer interfaces designed to treat neurological disorders.
201-500 employees
H1B Sponsorship
Neuralink has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (11)
2024 (14)
2023 (7)
2022 (5)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageTotal Funding
$1.34BKey Investors
CoreNest CapitalFounders FundVy Capital
2025-07-07Series Unknown
2025-06-17Secondary Market
2025-05-27Series E· $649M
Leadership Team
Dongjin Seo
Co-Founder, President & COO
Shivon Zilis
Director of Operations and Special Projects
Recent News
2025-12-29
Company data provided by crunchbase