Quality Engineer, Software Design Controls

• 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 (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.

• 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 81001-5-1).
• Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process.

The anticipated base salary for this position is expected to be within the following range.

Your actual base pay will be determined by your job-related skills, experience, and relevant education or training.

We also believe in aligning our employees’ success with the company's long-term growth.

As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.

Full-time employees are eligible for the following benefits listed below.

• An opportunity to change the world and work with some of the smartest and most talented experts from different fields
• Growth potential; we rapidly advance team members who have an outsized impact
• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity (RSUs) Temporary Employees & Interns excluded
• 401(k) plan Interns initially excluded until they work 1,000 hours
• Parental leave Temporary Employees & Interns excluded
• Flexible time off Temporary Employees & Interns excluded