{"id":74420,"url":"https://alion.io/job/neuralink-quality-engineer-software-design-controls","title":"Quality Engineer, Software Design Controls","company":{"id":8,"name":"Neuralink","domain":"neuralink.com","url":"https://alion.io/company/neuralink","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":74,"open_postings":77,"ghost_share":0.351,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":138,"computed_at":"2026-10-26T05:57:25Z"}},"role":"QA","role_family":"QA","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":103000,"max":191000,"currency":"USD","period":"year","gross":null,"usd_annual":191000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"FDA 510(k)","optional":true},{"name":"FMEA","optional":true},{"name":"IEC 62366","optional":true}],"status":"live","first_seen_at":"2026-08-21T20:30:00Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-26T20:30:13Z","board_verified":true,"closed_at":null,"days_open":66,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":65},"description":"About Neuralink:\nWe 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.\nTeam Description:\nJoin the Translational Team, where we generate the data that advances Neuralink’s brain-computer 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.\nJob Description and Responsibilities:\nThe Quality Engineer, Software Design Controls 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:\nWork 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.\nOwn 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.\nOwn 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.\nDebug 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.\nDevelop, 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.\nStay 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.\nRequired Qualifications:\nBachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline.\n3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices.\nStrong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls.\nDirect experience planning, executing, reviewing, and documenting software design control and verification/validation activities.\nWorking knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485.\nStrong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners.\nPreferred Qualifications:\nExperience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD).\nPrior 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.\nExperience with medical device design controls, ISO 14971 risk management (including software FMEA / SFMEA), cybersecurity risk assessment, and product development lifecycle in a regulated environment.\nExperience developing software design control guidelines, training programs, templates, or compliance workflows that accelerate product development.\nFamiliarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1).\nExperience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process.\nExpected Compensation:\nThe 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.\nBase Salary Range:\n$103,000—$191,000 USD\nWhat We Offer:\nFull-time employees are eligible for the following benefits listed below.\nAn opportunity to change the world and work with some of the smartest and most talented experts from different fields\nGrowth potential; we rapidly advance team members who have an outsized impact\nExcellent medical, dental, and vision insurance through a PPO plan\nPaid holidays\nCommuter benefits\nMeals provided\nEquity (RSUs) *Temporary Employees & Interns excluded\n401(k) plan *Interns initially excluded until they work 1,000 hours\nParental leave *Temporary Employees & Interns excluded\nFlexible time off *Temporary Employees & Interns excluded","description_format":"text","description_chars":5776,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible time off","Parental leave","Restricted stock units","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical & Healthcare Robotics","Neurotech & Neuromodulation"],"lifecycle":[{"event":"open","at":"2026-08-21T20:30:00Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 25 · green card filings: 1","filings_12m":25,"filings_prev_12m":12,"green_card_filings_12m":1,"median_offered_wage_usd":145962,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":38,"band":"fade","label":"Fading","p_open":0.6,"p_active":0.889,"p_room":0.72,"age_days":65,"expected_fill_days":138,"reasons":["seen:31","velocity","win:mid","crowd:"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":191000,"is_top_pay":true},"html_url":"https://alion.io/job/neuralink-quality-engineer-software-design-controls","json_url":"https://alion.io/job/neuralink-quality-engineer-software-design-controls.json","meta":{"generated_at":"2026-10-26T22:09:12Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":29921,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":8},"rest":"https://alion.io/mcp/rest/get_company?id=8"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fneuralink-quality-engineer-software-design-controls"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fneuralink-quality-engineer-software-design-controls"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fneuralink-quality-engineer-software-design-controls"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/neuralink-quality-engineer-software-design-controls\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fneuralink-quality-engineer-software-design-controls"}]}