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Systems Engineer III

Boston, MA
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 systems 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 integration, design transfer to manufacturing, system root cause analysis, stack-up analysis, manufacturing processes, manufacturing validations, key component sourcing, and supplier management. 

Your goal as a systems 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 ideation, development, integration verification, and manufacturing.  Additionally, you will document design and production processes in accordance with applicable product development procedures, quality, and regulatory requirements.

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.
  • Implement verification and validation with proper system, hardware, and software components traceability. Develop and execute test plans, test cases, and procedures to assess system performance, functionality, and reliability. 
  • 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.
  • Develop and maintain manufacturing procedures and records. 
  • Improve the manufacturing process to eliminate waste, reduce cost, and improve yield.
  • Support the transition of devices from development to production and lead root cause analysis of issues in production at suppliers and 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 experience with writing detailed technical specifications and documentation, including system requirements, design documents, standard operating procedures and test reports.
  • You have experience with stack-up analysis, preferably using SolidWorks. 
  • 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 experience in supplier management. 
  • Preferably, you have experience with injection molding and design for manufacturability (DFM). 
  • 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.

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