Systems Engineer (Medtech)

TL;DR

Systems Engineer (Medtech): Developing and optimizing EEG device systems for precision medicine in sleep and brain health with an accent on hardware integration and regulatory compliance. Focus on system verification, risk management (FMEA), and transitioning complex electromechanical systems from concept to commercial production.

Location: Hybrid based in Boston, MA

Salary: $120,000 – $140,000

Company

Leading at-home sleep test and EEG platform specializing in precision medicine for neurological and sleep disorders.

What you will do

• Develop and maintain EEG device systems in accordance with the Quality Management System (QMS).
• Elicit and document system and sub-system requirements ensuring coherence and traceability throughout the lifecycle.
• Implement V&V processes, developing and executing test plans and procedures to assess performance and reliability.
• Lead risk management activities, including hazard analysis and dFMEA/FMEA to mitigate system risks.
• Collaborate with Product Management and Algorithm teams to ensure seamless sub-system integration.
• Oversee the transition of devices to production and lead root cause analysis of issues at contract manufacturers.

Requirements

• BS in Engineering (5+ years experience) or MS in Engineering (3+ years experience).
• Experience defining architectures and technical specifications for multidisciplinary electromechanical systems.
• Proven track record in requirements traceability, V&V, and root cause investigations.
• Ability to lead cross-functional efforts across hardware, software, and firmware teams.
• Must be based in or able to work in a hybrid capacity from Boston, MA.

Nice to have

• Experience developing medical devices or other regulated/safety-critical products.
• Familiarity with medical device design controls and applicable regulatory standards.
• Proficiency with engineering tools such as Git, JIRA, GitHub, and OpenBOM.

Culture & Benefits

• Comprehensive compensation package including equity and PTO.
• Robust asynchronous work practices to support a first-class remote experience.
• Collaborative environment focused on curiosity, simplicity, and deep empathy towards users and patients.
• Opportunity to work on FDA-cleared technology revolutionizing brain health diagnostics.