Software Design Quality Engineer

About Neuralink:

We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed restore sight to the blind and revolutionize how humans interact with their digital world.

Team Description:

Join the Translational Team where we generate the data that advances Neuralinks braincomputer interface technologies from research and development through clinical evaluation and into market implementation. We produce the rigorous evidence required to support rapid development regulatory progress and the safe effective delivery of the technology to patients.

Job Description and Responsibilities:

The Software Design Controls Engineer will own software design control strategy processes documentation and continuous improvement across implantable electronics software surgical robotics software external systems and related non-product software. Responsibilities include:

• 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 Design History File (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.
• Stay current with advancements in medical device software standards regulatory science and related technologies; contribute to continuous improvement of compliance processes SOPs templates and knowledge sharing across teams.

Required Qualifications:

• Bachelors 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 (Medical Device Software Lifecycle Processes) ISO 14971 (Risk Management) and ISO 13485.
• Strong cross-functional communication skills and ability to drive issues to closure across engineering quality regulatory and external partners.

Preferred Qualifications:

• Experience with implants surgical robotics wireless systems or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD).
• Prior experience contributing software design control or V&V data to regulatory submissions (IDE 510(k) PMA or equivalent) and interfacing with FDA or notified bodies.
• Experience with medical device design controls ISO 14971 risk management (including software FMEA / SFMEA) cybersecurity risk assessment and product development lifecycle in a regulated environment.
• Experience developing software design control guidelines training programs templates or compliance workflows that accelerate product development.
• Familiarity with additional standards such as IEC 62366 (usability) 21 CFR Part 11 or cybersecurity guidance (FDA IEC).
• Experience writing test protocols reports deviations engineering rationales risk assessments and requirement traceability in a regulated or quality-controlled development process.