{"id":1292650,"url":"https://alion.io/job/blackrock-neurotech-senior-design-quality-engineer","title":"Senior Design Quality Engineer","company":{"id":63212,"name":"Blackrock Neurotech","domain":"blackrockneurotech.com","url":"https://alion.io/company/blackrock-neurotech","size_band":"51-200","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","truth_index":null},"role":"MedTech","role_family":"MedTech","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Salt Lake City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":96000,"max_usd":180000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":50},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false},{"name":"FMEA","optional":true},{"name":"ISO 13485","optional":true}],"status":"live","first_seen_at":"2026-09-26T03:44:05Z","employer_posted_date":"2026-09-26","last_verified_at":"2026-10-28T13:41:39Z","board_verified":true,"closed_at":null,"days_open":32,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":32},"description":"Build the systems that expand human capability\nAt Blackrock Neurotech, we’ve spent decades making the impossible possible - helping people move, speak, and reconnect with the world when they otherwise could not.We’ve seen that restoring function restores more than ability. It restores independence, identity, and agency.\nToday, we are building the next generation of human capability: brain-computer interfaces that are designed to be safe, scalable, and trusted in the real world. Our work is not only about reconnecting people to what was lost, but about expanding what is possible - creating a seamless interface between human intent and technology.\nThis is foundational work in a category-defining field. You will help build the infrastructure for a future where neural interfaces are invisible, reliable, and deeply human-centered.\nWorking at Blackrock Neurotech means:\nOwning meaningful, high-impact problems at the frontier of science and engineering\nBuilding alongside experienced, thoughtful peers across disciplines\nSolving technically complex challenges grounded in real human outcomes\nContributing to a culture that values rigor, clarity, and long-term thinking over noise\nThe Role\nAs a Senior Design Quality Engineer, you will provide hands-on design quality support for the development of Blackrock Neurotech’s brain-computer interface technologies and future medical devices. Working closely with R&D and engineering teams, you will help guide products through the development lifecycle, from early design and risk assessment through verification, validation, design transfer, and commercialization. You will bring deep medical device development experience and a pragmatic approach to Quality, helping teams navigate design controls and regulatory requirements while continuing to move innovative technologies forward.\nYou will work closely with Blackrock Neurotech’s BCI and R&D teams as they develop the next generation of brain-computer interface technologies. This is a highly cross-functional environment where Quality works alongside engineering and operations to solve complex product development challenges. The team is passionate about innovation and needs someone grounded in medical device development who can bring appropriate rigor to the work while helping teams move efficiently toward commercialization.\nYou will operate with meaningful ownership in a high-consequence environment, contributing to systems that must be precise, reliable, and durable.\nWhat You'll Do\nProvide hands-on Design Quality Engineering support throughout the product development lifecycle, from early design through commercialization \nPartner with electrical, mechanical, software, and systems engineering teams on design controls, requirements, risk management, verification and validation, and design transfer \nLead product risk management activities, including Risk Management Plans and Reports, hazard analyses and FMEAs in accordance with ISO 14971 \nDevelop and maintain design control documentation, including requirements, traceability matrices, validation plans, test methods, protocols, and reports \nApply statistical methods, root cause analysis, and sound engineering judgment to identify and resolve product and design quality issues \nSupport broader Quality activities associated with product development, including supplier qualification, ECOs, nonconformances, CAPAs, audits, and continuous improvement \nWhat You Bring\nBachelor’s degree in engineering or a related technical discipline with 8+ years of relevant experience, or a master’s degree with 5+ years of relevant experience; education or experience in electrical, mechanical, or software engineering is a plus \nDemonstrated Design Quality or Quality Engineering experience supporting medical device development from early concept through commercialization \nExperience developing Class III implantable medical devices, with hands-on knowledge of design controls, verification and validation, design transfer, and traceability \nStrong experience with medical device risk management and hazard analysis, including FMEA and ISO 14971 \nExperience applying statistical analysis and root cause analysis to product development and quality engineering challenges \nWorking knowledge of ISO 13485 and experience supporting or conducting quality system audits \nThis is an office-based, hybrid role in our Salt Lake City office. Employees are expected to work in the office at least 50% of the time.\nHow We Work\nWe are a small, experienced team working on consequential problems.\nWe take ownership of outcomes and follow through with clarity and accountability\nWe prioritize sustained, high-quality work over performative urgency\nWe value rigor, sound judgement and thoughtful decision-making\nWe collaborate deliberately: low ego, high trust and high context\nThis is a high-ownership role, but it is not an \"always-on\" one. 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