Systems Engineer (Hardware)

TL;DR

Systems Engineer (Hardware): Developing and maintaining EEG device systems for clinical sleep testing with an accent on system requirements, risk management, and regulatory compliance. Focus on cross-functional integration of hardware, firmware, and software components to ensure product quality and reliability from concept to commercialization.

Location: Must be based in the United States (with optional office hubs in Boston, New York, or San Francisco).

Company

hirify.global is a precision medicine platform revolutionizing sleep and brain health through AI-enabled at-home EEG diagnostics and novel therapeutic development.

What you will do

• Define and document system and sub-system requirements with full traceability.
• Lead verification and validation (V&V) activities, including test plan development and execution.
• Manage risk through hazard analysis (dFMEA/FMEA) and mitigation strategies.
• Collaborate with hardware, firmware, software, and algorithm teams to ensure seamless system integration.
• Support manufacturing transfer and lead root cause analysis for production issues.
• Maintain design documentation in accordance with QMS and regulatory standards.

Requirements

• Must be based in the United States.
• BS in engineering or related field with 5+ years of professional experience (or MS with 3+ years).
• Proven experience defining system architectures and technical specifications for electromechanical systems.
• Strong background in requirements traceability, risk analysis, and V&V throughout the product lifecycle.
• Experience leading cross-functional technical efforts across hardware, software, and firmware teams.
• Ability to support products through manufacturing transfer and sustaining engineering.

Nice to have

• Experience developing medical devices or safety-critical products.
• Familiarity with medical device design controls and regulatory standards.
• Proficiency with Git, JIRA, GitHub, and OpenBOM.

Culture & Benefits

• Robust asynchronous work practices supporting a first-class remote experience.
• Access to physical office hubs in major US cities.
• Commitment to scientific rigor and patient-centric innovation.
• Emphasis on curiosity, simplicity, and empathy in a diverse team environment.