Quality Engineer, Medical Software Design Controls

Neuralink; Austin (TX); On-site; USD 103,000 - 191,000; Full time

Benefits offered by this job

Equity (RSUs)

Excellent medical, dental, and vision

401(k) plan

Paid holidays

Job summary

Neuralink in Austin, TX seeks a Quality Engineer, Software Design Controls to own software design control strategy, plans, and documentation for implantable electronics, surgical robotics, and related software.

You will drive risk assessments, ensure traceability, and support design reviews to embed strong design control practices across the full software lifecycle, in a highly regulated environment.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.
• 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.
• Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.

Responsibilities

• Own software design control strategy, processes, documentation, and continuous improvement across implantable electronics software, surgical robotics software, external systems, and related non-product software.
• Drive design control risk assessments early and support design reviews to embed IEC 62304 practices.
• Own end-to-end software design control strategy and plan across full lifecycle for Class III and other regulated software in accordance with IEC 62304 and related standards.
• Debug quality and design control gaps using requirements management tools, traceability, code/architecture reviews, test results, and root-cause analysis.
• Develop and maintain software design control deliverables including plans, requirements specs, architecture docs, V&V plans/reports, risk files, traceability, change control, and linkages.
• Stay current with standards and contribute to process improvements, SOPs, templates, and knowledge sharing across teams.

Skills

Software design controls

Software quality assurance

Regulated medical devices

Cross-functional collaboration

IEC 62304 knowledge

ISO 14971/13485 knowledge

Requirements management tools

Education

Bachelor's degree in CS/Software/BME or related

Tools

Requirements management tools

Job description

Neuralink in Austin, TX seeks a Quality Engineer, Software Design Controls to own software design control strategy, plans, and documentation for implantable electronics, surgical robotics, and related software.

You will drive risk assessments, ensure traceability, and support design reviews to embed strong design control practices across the full software lifecycle, in a highly regulated environment.