Design, develop, and execute hardware and firmware test plans for EEG and home sleep test systems. Create test procedures, fixtures, and automation; perform functional, integration, system, and regression testing; troubleshoot and perform root cause analysis; document results to meet QMS, safety, and regulatory requirements (FDA/CE/60601); and collaborate with hardware, firmware, and quality teams through product development and manufacturing.
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 Waveband 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 a test engineer specializing in hardware and firmware, you will contribute to the development of new and modified EEG and Home Sleep Test 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, system, and software engineers. You are responsible for hardware characterization and verification tests, firmware unit tests, integration tests, verification tests, system integration, root cause analysis, and documentation to meet quality requirements.
Your goal as a hardware test 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 and production processes in accordance with applicable product development procedures, 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. This role is required to work from the Boston office around 3 days a week.
What success looks like:
- Develop and execute device testing in accordance with Beacon’s QMS.
- Develop and document test plans, test protocols, and test scripts for embedded systems, including hardware, firmware, and software, based on design specifications and requirements.
- Develop and maintain test procedures, fixtures, and equipment.
- Conduct functional, integration, system, and regression testing on hardware and firmware.
- Work closely with hardware and firmware engineers to troubleshoot and resolve product issues.
- Ensure products meet industry standards, safety, and regulatory requirements (e.g., FDA, CE, 60601).
- Implement process improvements and test automation to enhance product quality and testing efficiency.
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 of professional engineering experience with an MS degree or above.
- You have experience with writing detailed technical specifications and documentation, including requirements, test plans, protocols, and reports.
- You can read and follow electrical schematics.
- You have experience with embedded software that runs on a real-time operating system (RTOS).
- You have experience with scripting languages such as Python.
- You have experience with troubleshooting, debugging, and root cause analysis of hardware and firmware issues in electromechanical systems.
- You have experience with tools like Git/JIRA and platforms like GitHub.
- Preferably, you have 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.
Beacon Biosignals Boston, Massachusetts, USA Office
Boston, MA, United States
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