Test Engineer, Medical Devices

Beacon Biosignals; Boston (MA); Hybrid; USD 120,000 - 140,000; Full time

Benefits offered by this job

Remote work options

Job summary

Beacon Biosignals is transforming brain health through at-home EEG platforms. We seek a hardware test engineer to develop and execute tests for EEG and Home Sleep Test systems, collaborating with hardware, firmware, and software teams to ensure quality and regulatory compliance.

You will document test plans, procedures, and reports, contribute to design controls, and help advance from concept to commercialization. Boston-based hybrid role with remote options.

Qualifications

• BS in engineering or related field.
• 5 years with BS or 3 years with MS or higher.
• Experience writing detailed technical specifications, requirements, test plans, protocols, and reports.
• Ability to read and follow electrical schematics.
• Experience with embedded software on RTOS.
• Experience with Python scripting.
• Experience with debugging and root cause analysis of hardware/firmware in electromechanical systems.
• Experience with Git/JIRA and GitHub.
• Knowledge of medical device design controls and regulations (FDA/CE/60601).

Responsibilities

• Develop and execute device testing in accordance with QMS.
• Develop and document test plans, protocols, and scripts for embedded systems (hardware, firmware, software).
• Develop and maintain test procedures, fixtures, and equipment.
• Conduct functional, integration, system, and regression testing on hardware and firmware.
• Collaborate with hardware and firmware engineers to troubleshoot and resolve issues.
• Ensure products meet safety and regulatory requirements (FDA, CE, 60601).
• Implement process improvements and test automation to enhance quality and efficiency.

Skills

RTOS experience

Python scripting

Troubleshooting & root cause analysis

Hardware & firmware understanding

Written documentation

Cross-functional collaboration

Regulatory and design controls

Education

BS in engineering or related field

MS degree or above

Tools

Git/JIRA

GitHub

Job description

Beacon Biosignals is transforming precision medicine for the brain, from clinical development to clinical care. For Life Sciences partners, we offer the leading at-home EEG platform for clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our Diagnostics business is building the most comprehensive at-home platform for precision diagnostics, combining EEG and cardiopulmonary signals to deliver reimbursable assessments for sleep and central nervous system disorders. Together, we’re changing the way patients are diagnosed and 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 salary range for this role is $120,000 — $140,000. Salary ranges are determined using current market compensation data for this role and adjusted based on experience, skills, and location. 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.