System Engineer III

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at-home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Dreem EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our cloud-native analytics platform powers large-scale RWD/RWE retrospective and predictive studies. Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology. 

In this exciting and challenging role as the system engineer specializing in hardware, 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 VP of Device Systems and working closely with hardware, firmware, software engineers and product managers. You are responsible for system and sub-system requirements, system verification, risk management, system root cause analysis, manufacturing validations, and system integration with Algorithm and Platform teams. 

Your goal as a system engineer is to strive without reserve for the greatest quality and reliability in our products. To accomplish this goal, you will collaborate with other design, research, manufacturing and quality colleagues to develop products from concept to commercialization. You will contribute to product idealization, development, integration verification, and manufacturing. Additionally, you will document design in accordance with applicable product development processes, quality and regulatory requirements.

Beacon's robust asynchronous work practices ensure a first-class remote work experience, but we also have in-person office hubs available located in Boston, New York and Paris.

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 transition of 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 BS degree or 3+ years of professional engineering experience with MS degree.
• You have strong analytical and problem-solving skills, with the ability to analyze complex systems and identify opportunities for improvement.
• You have experience with writing detailed technical specifications and documentation, including system requirements, design documents, and test reports.
• You have experience with troubleshooting, debugging, and root cause analysis of issues in electromechanical systems.
• You have experience with tools like Git/JIRA/Confluence and platforms like GitHub.
• You have experience with scripting languages such as Python. 
• Preferably, you have the knowledge of design controls and regulations for medical devices.

The base salary range for this role is determined based on past experience, specific skills and qualifications. The base salary is one component of the total compensation package, which includes equity, PTO and other benefits.

At Beacon, we've found that cultural and scientific impact is driven most by those that lead by example. As such, we're always seeking new contributors whose work demonstrates an avid curiosity, a bias towards simplicity, an eye for composability, a self-service mindset, and - most of all - a deep empathy towards colleagues, stakeholders, users, and patients. We believe a diverse team builds more robust systems and achieves higher impact.