Neuralink is creating devices that enable a bi-directional interface with the brain and needs a Software Verification & Validation Engineer to ensure compliance with relevant regulatory standards
Requirements
- Proficiency in validation tools, scripting (e.g., Python), and code review processes
- 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)
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
Other
- 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
- Excellent analytical, problem-solving, and communication skills, with the ability to collaborate across interdisciplinary teams
- Ability to work with limited supervision
- Ability to collaborate across teams
