Beacon Biosignals

Healthcare

SystemsEngineer

$145–205k ~AI est. Boston, Massachusetts, United States Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Systems Engineer at Beacon Biosignals. Skills: Systems Engineering, Device Development, Risk Management, Verification and Validation. Contribute to development of new EEG device systems. Meet application requirements”

What You'll Achieve.

Strive for quality; Strive for reliability

Industry & Context.

Healthcare
Problems you'll solve

Analytical skills; Problem-solving skills; Identify technical risks; Drive system-level improvements; Root cause investigations

What They're Looking For.

Must Have

BS in engineering, 5+ years engineering experience (BS), 3+ years engineering experience (MS), Analytical and problem-solving skills, Experience leading cross-functional technical efforts, Experience defining system architectures, Experience developing technical specifications, Experience with requirements traceability, Experience with risk analysis, Experience with verification & validation, Experience with root cause investigations, Experience supporting products through manufacturing transfer, Experience with sustaining engineering, Experience with change management processes

Nice to Have

Experience with Git, Experience with JIRA, Experience with GitHub, Experience with OpenBOM, Experience developing medical devices, Experience with regulated products, Experience with safety-critical products, Familiarity with medical device design controls, Familiarity with risk management practices, Familiarity with applicable regulatory standards

What You'll Do.

Contribute to development of new EEG device systems

Meet application requirements

Meet business requirements

Meet customer requirements

Meet regulatory requirements

Manage system requirements

Manage sub-system requirements

Perform system verification

Perform risk management

Perform system root cause analysis

Perform manufacturing validations

Integrate systems with Algorithm teams

Integrate systems with Platform teams

Develop products from concept to commercialization

Contribute to product idealization

Contribute to product development

Contribute to integration verification

Contribute to validation

Contribute to manufacturing

Develop device development

Maintain device development

Apply Systems Engineering principles

Elicit system requirements

Analyze system requirements

Document system requirements

Elicit sub-system requirements

Analyze sub-system requirements

Document sub-system requirements

Implement verification

Trace system components

Trace hardware components

Trace software components

Develop test procedures

Execute test procedures

Assess system performance

Assess system functionality

Assess system reliability

Contribute to risk management

Perform hazard analysis

Interface with Product Management

Interface with Algorithm Development team

Interface with Platform team

Ensure sub-system integration

Support technical documents

Write technical documents

Support process-related documents

Write process-related documents

Support device transition to production

Lead root cause analysis

Analyze issues in production

How You'll Work.

Team & Collaboration

Device Team; Hardware engineers; Firmware engineers; Software engineers; Product managers; Algorithm teams; Platform teams; Design colleagues; Research colleagues; Manufacturing colleagues; Quality colleagues; Cross-functional technical efforts

Communication Scope

Written communication; Verbal communication; Technical concepts

Process & Methodology

Product development lifecycle, Manufacturing transfer, Sustaining engineering, Change management

Full Job Description

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 experi

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