Senior Systems Engineer

Senior Systems Engineer - Medical Devices & Cloud Systems

Location: Acton, MA (Hybrid)

Work Location: Hybrid (CA or MA)

Pay Rate: Up to $85/hour

Industry: Medical Devices | Wearables | Cloud & IoT

We are seeking a Senior Systems Engineer to serve as a technical lead supporting the design and development of innovative, FDA-regulated wearable medical devices and associated cloud and data management systems. This role is critical to advancing next-generation product development from concept through commercialization and will work across hardware, software, mechanical, and systems disciplines.

Key Responsibilities

• Act as a technical leader on cross-functional development teams including electrical, software, mechanical, manufacturing, quality, and regulatory engineering
• Lead system definition activities, including:
  
  
  
  • User needs development
  • System and product requirements
  • Use-case and workflow definitions
  
  
  
  
• Define and document system and subsystem architectures across hardware, software, and cloud components
• Identify, assess, and document system hazards, failure modes, and risk mitigation strategies
• Collaborate with internal Centers of Excellence (CoEs) and external suppliers to evaluate, integrate, and qualify components and subsystems
• Serve as a technical consultant for system integration, verification, and validation activities, including creation of verification plans, protocols, and reports
• Maintain end-to-end traceability between requirements, design outputs, verification/validation, and risk management artifacts to ensure a complete Design History File (DHF)
• Support proposal development, project planning, cost estimates, and leadership presentations
• Provide technical guidance on software development artifacts such as architecture documents, requirements, and failure mode analyses
• Participate in Agile development ceremonies, including PI Planning, Retrospectives, and Inspect & Adapt
• Mentor and support junior engineers, fostering knowledge sharing and technical growth

Required Qualifications

• Bachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical, or related discipline)
• 3-7+ years of experience in systems engineering or systems-focused roles within multidisciplinary development teams
• 2+ years of experience leading cross-functional engineering teams
• Strong expertise in systems engineering best practices, including:
  
  
  
  • Requirements management
  • Design trade studies and cost-benefit analysis
  • Hazard analysis and risk management
  
  
  
  
• Experience supporting long-term R&D programs from feasibility through commercialization
• Hands-on experience with ALM tools such as Polarion, Helix ALM, or DOORS
• Experience performing root cause analysis and technical troubleshooting
• Proven experience writing verification plans, protocols, and reports in a regulated industry
• Data analysis experience using Minitab, JMP, or MATLAB
• Strong knowledge of medical device regulations and standards, including:
  
  
  
  • ISO 13485
  • ISO 14971
  • IEC 62304
  • 21 CFR Part 820.30 (Design Controls)
  
  
  
  
• Excellent communication skills with the ability to engage technical and non-technical stakeholders
• Strong organizational skills with the ability to prioritize in a fast-paced development environment

Preferred Skills & Experience

• Master's degree in Engineering; Systems Engineering training or certification strongly preferred
• Formal training in Systems Engineering methodologies
• 1-2 years of experience with Model-Based Systems Engineering (MBSE)
• 1-2 years of experience working in Agile software development environments; Agile certification a plus
• Experience managing change orders in PLM systems such as Arena
• Demonstrated success developing FDA-regulated medical devices, particularly in drug delivery systems
• Experience with reliability engineering practices (HALT, HASS, performance modeling, prediction testing)
• Experience collaborating with third-party vendors and development partners
• Domain expertise in one or more of the following:
  
  
  
  • Cloud systems and security
  • BLE, NFC, and wireless communications
  • Circuit design
  
  
  
  
• Six Sigma training or certification
• 2-3 years of experience with cloud technologies (AWS), including microservices, REST, and HTTP
• Familiarity with IoT, mobile technologies, and GDPR compliance
• Experience with SolidWorks or Pro/Engineer
• Software development experience (C++, Java, Android UI)

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

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