Software Design Controls Engineer (Medical Devices)

Socket.dev; Austin (TX); On-site; USD 103,000 - 191,000; Full time

Benefits offered by this job

Equity RSUs

401(k) plan

Medical insurance (PPO)

Paid holidays

Commuter benefits

Meals provided

Parental leave

Flexible time off

Job summary

Neuralink is hiring a Quality Engineer, Software Design Controls to own the software lifecycle strategy for implantable electronics and related systems. You will work with software and firmware teams to embed robust design controls and ensure compliance with IEC 62304, ISO 14971, and ISO 13485 across Class III software.

You will develop and maintain design control deliverables, assess design changes for risk and traceability, and drive continuous improvement in regulatory submissions and DHF

Qualifications

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
• 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.
• Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls.
• Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities.
• Working knowledge of IEC 62304, ISO 14971, and ISO 13485.

Responsibilities

• Work directly with software and firmware teams to identify design control and software lifecycle risks early, drive robust mitigations, and support design reviews to embed strong design control and IEC 62304 practices.
• Own software design control impact assessments for design changes within the medical device design control process; evaluate effects on requirements, architecture, risk controls, verification/validation, and traceability; determine re-test, analysis, or documentation needs; and update risk assessments, protocols, and DHF content to maintain ongoing compliance.
• Own end-to-end software design control strategy and plan/execute activities supporting the full software lifecycle (requirements, architecture, detailed design, implementation, verification, validation, risk management, and release) for Class III and other regulated software in accordance with IEC 62304, ISO 14971, ISO 13485, and related standards.
• Debug software quality and design control gaps using requirements management tools, traceability matrices, code/architecture reviews, test results, anomaly data, and root-cause analysis techniques; recommend effective process and design mitigations.
• Develop, execute, and maintain software design control deliverables including design and development plans, software requirements specifications, architecture documents, verification/validation plans and reports, risk management files, traceability matrices, change control records, and requirement-to-test linkages for complex systems involving implants, chargers, robots, and supporting software.

Skills

Software design controls

SDLC in regulated environments

Regulatory standards

Design reviews

Traceability

Education

Bachelor’s degree in CS/Engineering/Biomedical or related

Job description

Neuralink is hiring a Quality Engineer, Software Design Controls to own the software lifecycle strategy for implantable electronics and related systems. You will work with software and firmware teams to embed robust design controls and ensure compliance with IEC 62304, ISO 14971, and ISO 13485 across Class III software.

You will develop and maintain design control deliverables, assess design changes for risk and traceability, and drive continuous improvement in regulatory submissions and DHF