Systems Engineer

What You Will Be Doing

Beacon Biosignals is on a mission to revolutionize precision medicine for sleep and brain health. You will contribute to the development of new, modified EEG device systems that meet application, business, customer and regulatory requirements. You will be working in the Device Team, reporting to the Director of Device Engineering and working closely with hardware, firmware, software engineers and product managers.

What Success Looks Like

• Develop and maintain device development in accordance with Beacon’s QMS.
• Apply Systems Engineering principles and best practices to new product development.
• Elicit, analyze, and document system and sub-system requirements, ensuring coherence and traceability throughout the product lifecycle.
• Implement verification and validation with proper traceability for system, hardware, and software components.
• Develop and execute test plans, test cases, and procedures to assess system performance, functionality, and reliability.
• Actively contribute to risk management, including hazard analysis (dFMEA and FMEA) and risk mitigation.
• Identify, assess, and manage risks associated with system development, production, and post-production maintenance.
• Interface with Product Management, Algorithm Development team, and Platform team to ensure smooth integration of sub-systems of Beacon’s products.
• Support and write technical and process-related documents.
• Support the transition of the device from development to production, and lead root cause analysis of issues in production at contract manufacturers.

What You Will Bring

• Education: BS in engineering, or related field.
• Work Experience (post-graduate): 5+ years of professional engineering experience with a BS degree or 3+ years with an MS degree.
• Strong analytical and problem-solving skills, with the ability to analyze complex systems, identify technical risks, and drive system-level improvements.
• Experience leading cross-functional technical efforts across hardware, software, firmware, and operations teams to deliver complex integrated systems.
• Experience defining system architectures and developing detailed technical specifications and documentation for multidisciplinary electromechanical systems, including system requirements, design documents, test plans, and test reports.
• Experience with requirements traceability, risk analysis, verification & validation (V&V), and root cause investigations throughout the product development lifecycle.
• Strong written and verbal communication skills, with the ability to communicate complex technical concepts effectively to both technical and non-technical stakeholders.
• Experience working in fast-paced environments with evolving requirements and the ability to independently drive technical analysis and decision-making.
• Experience supporting products through manufacturing transfer, sustaining engineering, and change management processes.

Preferred

• Experience with engineering collaboration and development tools like Git and JIRA, as well as platforms like GitHub and OpenBOM.
• Experience developing medical devices or other regulated/safety-critical products.
• Familiarity with medical device design controls, risk management practices, and applicable regulatory standards.