Manufacturing Systems Engineer Jobs in Boston, MA

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.