Systems Engineer

Posted Yesterday
Be an Early Applicant
Boston, MA, USA
In-Office
120K-140K Annually
Senior level
Artificial Intelligence • Healthtech • Machine Learning
The Role
Lead hardware-focused systems engineering for FDA-cleared at-home EEG/sleep devices: define system and subsystem requirements, perform V&V and risk management (dFMEA/FMEA), execute test plans, drive integration with algorithm and platform teams, support manufacturing transfer, root cause analysis, and document per QMS and regulatory requirements.
Summary Generated by Built In

What you will be doing:

Beacon Biosignals is on a mission to revolutionize precision medicine for sleep and brain health. We are the leading at-home sleep test and EEG platform supporting clinical sleep testing and development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared at-home sleep testing devices integrate multi-channel cardiopulmonary and EEG signals into a single streamlined workflow powered by AI-enabled analytics. With a dedication to patient experience and scientific rigor, Beacon enables high-quality clinical diagnostics at scale and powers the development of novel neuromedicines. 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 Director of Device Engineering 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, validation, 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 Paris, Boston, New York, or the San Francisco Bay Area. This is a hybrid role based in Boston.

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.
  • Preferred: Experience developing medical devices or other regulated/safety-critical products.
  • Preferred: Familiarity with medical device design controls, risk management practices, and applicable regulatory standards.

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.

Skills Required

  • BS in engineering or related field
  • 5+ years professional engineering experience with a BS degree (or 3+ years with an MS)
  • Strong analytical and problem-solving skills
  • Experience leading cross-functional technical efforts across hardware, software, firmware, and operations
  • Experience defining system architectures and developing detailed technical specifications and documentation for multidisciplinary electromechanical systems
  • Experience with requirements traceability, risk analysis, verification & validation (V&V), and root cause investigations
  • Strong written and verbal communication skills
  • Experience working in fast-paced environments with evolving requirements and ability to independently drive technical analysis and decision-making
  • Experience supporting products through manufacturing transfer, sustaining engineering, and change management processes
  • Experience with engineering collaboration and development tools like Git and JIRA, and 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

Beacon Biosignals Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Beacon Biosignals and has not been reviewed or approved by Beacon Biosignals.

  • Healthcare Strength Core insurance coverage includes medical, dental, and vision, aligning with standard employer health benefits. These foundations are clearly communicated as part of the package.
  • Leave & Time Off Breadth Paid holidays, sick time, and “generous PTO” are highlighted. This range of leave types indicates multiple avenues for time away from work.
  • Parental & Family Support Parental leave and family medical leave are explicitly included. This signals support for family and caregiving needs beyond standard PTO.

Beacon Biosignals Insights

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The Company
HQ: Boston, MA
40 Employees
Year Founded: 2019

What We Do

Brain monitoring is not easily accessible, interpretable or actionable. We're going to fix this, and we'd like you to help. With improved access to brain data and the right tools to act on it, clinicians could intervene in real-time, match life-altering therapies to the patients they benefit most, and treat previously untreatable neurological and psychiatric diseases. Beacon is building an interdisciplinary and uniquely talented team to implement this future.

Why Work With Us

We value curiosity and innovation. We approach problems like research - problems are an opportunity to learn something new and improve upon an outcome.

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