# Systems Engineer

**Company:** [Beacon Biosignals](https://hotfix.jobs/companies/beacon-biosignals)
**Location:** Boston, MA
**Role:** Embedded Engineering
**Experience:** 5+ years
**Skills:** Systems Engineering, Requirements Management, Verification And Validation, Risk Management, Fmea, Dfmea, Root Cause Analysis, Hardware Integration, Firmware Integration, Medical Device Development
**Posted:** 2026-06-09

> Systems Engineer (hardware focus) responsible for system requirements, verification/validation, risk management, and cross-functional integration of EEG medical devices from concept through manufacturing.

## Job Description

## 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.

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