Neuralink
Software Design Quality Engineer
About this role
Neuralink seeks a Software Design Quality Engineer to establish and oversee software design control strategies for brain-computer interface medical devices. You'll manage compliance with IEC 62304 and related standards across implantable electronics, surgical robotics, and external systems, ensuring rigorous lifecycle documentation and risk management from development through clinical deployment.
What you'll do
- Own software design control strategy and lifecycle processes for Class III regulated software across implants, robotics, and external systems
- Conduct design control impact assessments for changes, evaluating effects on requirements, architecture, risk controls, verification/validation, and traceability
- Debug quality and compliance gaps using requirements management tools, traceability matrices, code reviews, and root-cause analysis
- Develop and maintain design control deliverables including requirements specs, architecture documents, V&V plans/reports, and DHF content
- Collaborate with software, firmware, engineering, quality, and regulatory teams to identify risks early and support design reviews
- Stay current with medical device software standards and drive continuous improvement of compliance processes and SOPs
What they're looking for
- IEC 62304, ISO 14971, and ISO 13485 standards knowledge
- Software design controls and design assurance
- Requirements management and traceability
- Verification and validation planning and execution
- Risk management and FMEA/SFMEA
- Medical device regulatory compliance
- Cross-functional communication and stakeholder management
- Technical documentation and design review expertise
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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 developing design control strategies for Class III medical device software. How did you ensure IEC 62304 compliance across different software components?
- Walk us through a time you identified and mitigated a significant software design control or verification/validation gap. What tools and techniques did you use?