Senior Design Quality Engineer

About the role

At 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. Today, 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. This 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. Working at Blackrock Neurotech means owning meaningful, high-impact problems at the frontier of science and engineering, building alongside experienced, thoughtful peers across disciplines, solving technically complex challenges grounded in real human outcomes, contributing to a culture that values rigor, clarity, and long-term thinking over noise.

Responsibilities

• Provide hands-on Design Quality Engineering support throughout the product development lifecycle, from early design through commercialization
• Partner with electrical, mechanical, software, and systems engineering teams on design controls, requirements, risk management, verification and validation, and design transfer
• Lead product risk management activities, including Risk Management Plans and Reports, hazard analyses and FMEAs in accordance with ISO 14971
• Develop and maintain design control documentation, including requirements, traceability matrices, validation plans, test methods, protocols, and reports
• Apply statistical methods, root cause analysis, and sound engineering judgment to identify and resolve product and design quality issues
• Support broader Quality activities associated with product development, including supplier qualification, ECOs, nonconformances, CAPAs, audits, and continuous improvement

Requirements

• Bachelor’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
• Demonstrated Design Quality or Quality Engineering experience supporting medical device development from early concept through commercialization
• Experience developing Class III implantable medical devices, with hands-on knowledge of design controls, verification and validation, design transfer, and traceability
• Strong experience with medical device risk management and hazard analysis, including FMEA and ISO 14971
• Experience applying statistical analysis and root cause analysis to product development and quality engineering challenges
• Working knowledge of ISO 13485 and experience supporting or conducting quality system audits

Schedule

This 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.