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Software Design Quality Engineer

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Software Design Quality Engineer in USA

  • Neuralink
  • Full time
  • Email
  • Austin, TX

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.
  • Partner with software and firmware teams to identify design control and software lifecycle risks, drive mitigations, and support design reviews using IEC 62304 practices.
  • Lead design control impact assessments for changes and evaluate effects on requirements, architecture, risk controls, verification and validation, and traceability.
  • Plan and execute software lifecycle activities for Class III and other regulated software, including requirements, architecture, design, implementation, verification, validation, risk management, and release.
  • Debug software quality and design control gaps using requirements management tools, traceability matrices, code and architecture reviews, test results, anomaly data, and root-cause analysis.
  • Develop and maintain design and development plans, software requirements specifications, architecture documents, verification and validation plans and reports, risk files, traceability matrices, change records, and requirement-to-test linkages.
  • Maintain risk assessments, protocols, and Design History File content to support ongoing compliance.
  • Contribute to improvements in compliance processes, standard operating procedures, templates, and cross-functional knowledge sharing.

Requirements

  • Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related technical discipline.
  • At least 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 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.
  • Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device or Software in a Medical Device is preferred.
  • Experience contributing software design control or verification and validation data to regulatory submissions and interfacing with the FDA or notified bodies is preferred.
  • Experience with medical device design controls, ISO 14971 risk management including software FMEA or SFMEA, cybersecurity risk assessment, and regulated product development lifecycles is preferred.
  • Experience developing software design control guidelines, training programs, templates, or compliance workflows is preferred.
  • Familiarity with IEC 62366, 21 CFR Part 11, or cybersecurity guidance including FDA guidance and IEC 81001-5-1 is preferred.
  • Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in regulated or quality-controlled development processes is preferred.

Benefits

  • Full-time employees receive medical, dental, and vision insurance through a PPO plan.
  • Paid holidays, commuter benefits, meals, equity in the form of RSUs, a 401(k) plan, parental leave, and flexible time off are offered; some benefits exclude temporary employees and interns.
  • The role is full-time.

Salary: $103k - $191k/yr

Neuralink

Neuralink is a neurotechnology company building a generalized input/output platform for the brain. Our work has the potential to restore autonomy to those with unmet medical needs and fundamentally transform how humans interact with the world. Our core technology is an implantable brain-computer ...

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