Neuralink
Quality Engineer, Software Design Controls
About this role
Neuralink seeks a Quality Engineer to establish and manage software design control strategies across implantable electronics, surgical robotics, and external systems. The role focuses on ensuring regulatory compliance with IEC 62304 and related standards while supporting the development of brain-computer interface technologies from R&D through clinical and commercial stages.
What you'll do
- Develop and execute end-to-end software design control strategies aligned with IEC 62304, ISO 14971, and ISO 13485 for Class III regulated software
- Conduct design control impact assessments for software changes and determine verification, validation, and documentation needs
- Create and maintain design control deliverables including requirements specifications, architecture documents, V&V plans, risk management files, and traceability matrices
- Identify and mitigate software lifecycle risks early through collaboration with engineering and design review support
- Debug quality gaps using requirements management tools, code reviews, and root-cause analysis to recommend process improvements
- Stay current with medical device software standards and contribute to continuous improvement of compliance processes and templates
What they're looking for
- Software design controls and design assurance for medical devices
- IEC 62304, ISO 14971, ISO 13485 standards
- Software development lifecycle (SDLC) in regulated/safety-critical environments
- Requirements management and traceability matrix development
- Verification and validation planning and execution
- Risk management and software failure mode analysis (SFMEA)
- Cross-functional communication and stakeholder management
- Regulatory submission support (IDE, 510(k), PMA)
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Neuralink
Neuralink develops brain-computer interface technology and neurosurgical robots to enable direct interaction between the brain and computing systems. The company is hiring engineers across clinical implementation, user interface design, manufacturing, and software development to support its pioneering medical devices and surgical systems.
- Website
- neuralink.com
Likely interview questions
- Describe your experience implementing IEC 62304 design controls in a medical device project; what challenges did you encounter and how did you address them?
- Walk us through how you've managed traceability between requirements, design, test cases, and risk controls for a complex software system.