Senior Design Quality Engineer

Blackrock Neurotech LLC; Salt Lake City (UT); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Blackrock Neurotech LLC in Salt Lake City is seeking a Senior Design Quality Engineer to guide medical device development from concept to commercialization. You will apply ISO 14971, ISO 13485, and risk management practices across electrical, mechanical, and software domains in a cross-functional team.

You will own design controls, verification and validation plans, and supplier qualification in a hybrid office setting, balancing rigorous quality with rapid innovation in a high-consequence

Qualifications

• Bachelor's degree in engineering or related technical discipline; 8+ years of relevant experience, or master's with 5+ years
• Experience supporting medical device development from concept through commercialization
• Experience with ISO 14971 risk management and FMEA
• Familiarity with ISO 13485 and design controls

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

Skills

Design Quality Engineering

Medical device development

Risk management

FMEA

Statistical analysis

Education

Bachelor's degree in engineering or related technical discipline

Master's degree in engineering (optional)

Tools

ISO 14971

ISO 13485

Design controls

Job description

Build the systems that expand human capability

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

The Role

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.

What You'll Do

• 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 You Bring

• 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 developingClass 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

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.

How We Work

We are a small, experienced team working on consequential problems.

• We take ownership of outcomes and follow through with clarity and accountability
• We prioritize sustained, high-quality work over performative urgency
• We value rigor, sound judgement and thoughtful decision-making
• We collaborate deliberately: low ego, high trust and high context

This is a high-ownership role, but it is not an "always-on" one. We expect strong work and our people to have a life outside of it.