Clinical Study Manager Jobs in Utah (NOW HIRING)

Job Summary:
Blackrock Neurotech is dedicated to expanding human capability through innovative brain-computer interfaces. The BCI Software Team Lead will translate research into reliable software, leading a team of engineers to develop systems that process real-time neural data while ensuring compliance and performance.
Responsibilities:
• Build and shape real-time brain-computer interface software systems that move research into clinical and patient-facing applications
• Directly influence how people interact with critical neurotechnology that restores communication, mobility, and independence
• Contribute to work that improves lives through safer, more capable, and more reliable BCI systems that patients depend on daily
• Lead and mentor a team of 5–8 engineers while actively contributing to the codebase
• Own system architecture and technical direction for real-time BCI application software
• Design and maintain low-latency, high-reliability streaming signal-processing pipelines
• Ensure deterministic performance across CPU, GPU, and/or FPGA-accelerated components
• Strengthen cybersecurity and reliability of connected medical-device software systems
• Define and enforce engineering standards, design review processes, and best practices
• Drive software readiness for clinical studies, trials, and regulated device environments
• Balance research prototyping with production-grade software development and long-term maintainability
• Partner closely with neuroscientists on signal processing and algorithm requirements
• Collaborate with hardware and firmware teams on system integration and performance
• Work with clinical teams on study design, trial software needs, and deployment readiness
• Coordinate with Regulatory and Quality teams on documentation, traceability, and verification requirements
Qualifications:
Required:
• 10+ years combined education and experience in software engineering, with at least 3 years building production software in the field
• 3+ years leading or managing engineering teams, with demonstrated success running teams through hiring, mentorship, goal-setting, and performance management
• Proven track record of shipping production software in real-time, embedded, or safety-critical domains
• Experience developing software for, or within, a regulated environment (e.g., for medical device, ISO 13485, FDA QSR/QMSR, or equivalent)
• Demonstrated ability to define and communicate software architecture for complex, multi-component systems to both technical and non-technical stakeholders
• Strong command of real-time architectures, data streaming, and signal processing, including determinism, latency constraints, and resource management
• Proficiency in real-time and/or embedded software development
• Hands-on proficiency in Python for data pipelines, test automation, and prototyping
• Working experience with high-performance compute for low-latency signal processing using GPU (Metal, CUDA, OpenCL), FPGA, or equivalent
• Familiarity with cybersecurity principles for networked or connected medical device software (threat modeling, secure coding practices, vulnerability management)
• Ownership mindset that takes accountability for individual, team, and department outcomes and follows problems through to resolution
• Leads by example, balancing hands-on technical contribution with mentorship and people leadership rather than choosing one over the other
• Sound technical judgment under ambiguity, with the discernment to know when to invest in productization versus prototype and when to escalate
• Curiosity and adaptability through active tracking of advances in real-time systems and neurotechnology and adjusts approach as the company, products, and regulatory landscape evolve
• Excellent communicator and cross-functional coordinator across neuroscience, hardware, firmware, clinical, regulatory, and quality partners
Preferred:
• Prior experience building software for brain-computer interfaces, neural recording systems, or closed-loop neurostimulation
• Deep understanding of real-time and multi-threaded systems, including OS-, scheduler-, or kernel-level performance tuning and debugging
• Strong systems thinking with proven ability to tightly integrate software with hardware, firmware, and clinical workflows
• Experience supporting FDA submissions (IDE, 510(k), De Novo) in a technical or engineering leadership role
• Familiarity with IEC 62304 and design-controlled development, including authoring or reviewing software lifecycle and traceability artifacts
• Experience working within clinical study or trial environments, including software deployment to sites, protocol alignment, and safety reporting
• Experience in startup, scale-up, or deep-tech environments with rapidly shifting priorities and lightweight process structure
• Proven ability to balance research prototyping with disciplined productization, taking ideas from early exploration to regulated, shipped systems without losing technical intent
• Track record of mentoring engineers and building high-trust, inclusive teams that perform under pressure and through ambiguity
• Open-source contributions, publications, or conference talks in real-time systems, neurotechnology, signal processing, or medical device software
• Background in neuroscience, biomedical engineering, or related fields enabling fluent collaboration with scientific and clinical partners
• Experience hiring and scaling engineering teams through rapid growth or regulatory transition periods
Company:
Blackrock Neurotech is the platform for brain-computer interface (BCI) technology and manufacturing. Founded in 2008, the company is headquartered in Salt Lake City, USA, with a team of 51-200 employees. The company is currently Growth Stage.