Advantage Technical · 1 day ago
Senior System Engineer
Acton, MA
Full-time
Onsite
Mid, Senior Level
$83/hr - $84/hr
3+ years expAdvantage Technical is seeking a Senior Systems Engineer to serve as a technical lead in the design and development of innovative wearable medical devices. This role involves leading systems engineering activities across both existing and new product development programs, collaborating with cross-functional teams to deliver project milestones.
Staffing & Recruiting
Hiring Manager
Damarys Zambrano, MSIOP
Responsibilities
Serve as a core member of cross-functional project teams, collaborating with electrical, software, mechanical, manufacturing, and quality engineers to deliver project milestones
Lead system definition activities, including development of user needs, product requirements, and use-case descriptions
Define system and subsystem architectures to support system development
Identify, document, and manage system hazards, failure modes, and risk mitigations
Partner with technical centers of excellence, subject matter experts, and suppliers to assess, select, integrate, and qualify key components and subsystems
Act as a technical consultant for integration, subsystem, and system verification activities, including development of verification plans, protocols, and reports
Create and maintain full traceability between design inputs, design outputs, verification and validation activities, and risk management artifacts to ensure a complete and compliant Design History File (DHF)
Support proposal development, project planning, effort estimation, and provide technical updates and status reports to leadership and key stakeholders
Serve as a technical consultant for software development deliverables, including design/architecture documentation, requirements, and failure mode analyses
Participate in Agile ceremonies such as Program Increment (PI) Planning, Retrospectives, and Inspect & Adapt sessions
Mentor and support junior engineers, fostering knowledge sharing and professional development
Qualification
Required
Bachelor of Science in Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical, or related discipline)
3–7+ years of experience working as a Systems Engineer or in a role with systems engineering responsibilities within multidisciplinary development teams
Minimum of 2 years of experience leading cross-functional development teams
Demonstrated expertise in systems engineering practices, including requirements management, design trade-off analysis, cost-benefit analysis, hazard identification, and risk assessment
Experience supporting long-term R&D development programs across concept/feasibility, development, and commercialization phases
Hands-on experience with Application Lifecycle Management (ALM) tools such as Polarion ALM, Helix ALM, or DOORS
Experience conducting root cause analysis and troubleshooting
Proven experience authoring verification plans, protocols, and reports in a regulated industry
Experience with data analysis tools such as Minitab, JMP, or MATLAB
Strong working knowledge of medical device regulations and standards, including ISO 13485, ISO 14971, IEC 62304, and 21 CFR Part 820.30 (Design Controls)
Demonstrated ability to work effectively within a Quality Management System (QMS) in cross-functional environments involving R&D, V&V, manufacturing, marketing, clinical, regulatory, and quality teams
Excellent written and verbal communication skills with the ability to engage at multiple organizational levels
Strong organizational skills with the ability to prioritize effectively in a dynamic environment
Preferred
Master of Science degree preferred; Systems Engineering training and/or certification is a plus
Formal training in established systems engineering methodologies
1–2 years of experience in Model-Based Systems Engineering (MBSE)
1–2 years of experience working in Agile software development environments; Agile certification is a plus
Experience managing change orders within a Product Lifecycle Management (PLM) tool (e.g., Arena PLM)
Demonstrated success developing innovative FDA-regulated medical devices, preferably within the drug delivery domain
Experience with reliability engineering practices, including data-driven modeling, performance testing, prediction, HALT, and HASS
1–2 years of experience collaborating with third-party partners or vendors
Domain expertise in one or more of the following areas: cybersecurity, cloud technologies, wireless communication (BLE, NFC), or circuit design
Six Sigma training or certification
2–3 years of experience with cloud technologies (e.g., AWS) and a solid understanding of microservices, REST APIs, and HTTP
General understanding of mobile technologies, IoT, communication protocols, and GDPR compliance
Experience with CAD tools such as SolidWorks or Pro/ENGINEER
Experience with software tools and coding languages including C++, Java, and Android UI development
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
10001+ employees
H1B Sponsorship
Advantage Technical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (7)
2021 (10)
2020 (48)
Funding
Current Stage
Late StageCompany data provided by crunchbase