Senior Design Quality Engineer

Blackrock Neurotech • Salt Lake City, UT

3d • Hybrid

About The Position

As 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. You 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. You will operate with meaningful ownership in a high-consequence environment, contributing to systems that must be precise, reliable, and durable.

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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior