Senior Systems Engineer

Sr. System EngineerTrident Consulting is seeking a Sr. System Engineer for one of our clients in Burlington, MA. A global leader in business and technology services.Position Overview:We are seeking a highly skilled, self-motivated and experienced Senior System Engineer to join our R&D team.The successful candidate will support system development, integration, verification, and sustaining activities for a complex electromechanical product.This role is hands-on and execution-focused, working closely with hardware, software, firmware, mechanical, quality, and regulatory teams to ensure system requirements are implemented, integrated, and verified. The ideal candidate can quickly ramp up, contribute immediately, and support active development and integration efforts.Responsibilities:Design and requirement managementSupport system-level requirements for development, allocation, and traceability in Helix or Jama.Assist with system architecture definition and interface management across hardware, software, firmware, and mechanical domainsMaintain and update system documentation, including requirements, specifications, and design artifactsDesign, set up, and maintain test fixtures for boards and subsystem validation.Develop and maintain mechanical and electrical documentation packages for test fixtures, including drawings, schematics, and test reports. System IntegrationExecute and support system integration of hardware, software, and firmware components at subsystem and system levelsSupport Verification and Validation (V&V) by defining, specifying, and supporting testing, analysis, and integration activitiesActively participate in system bring-up, integration testing, and debuggingDevelop a strong understanding of end-to-end system performance and behaviorCollaborate with Subject Matter Experts (SMEs) to investigate, troubleshoot, and drive resolution of system-level issues during development and integrationProvide timely technical feedback to support issue resolution and project schedules Verification, Validation, and DocumentationDevelop and support system test plans, protocols, and proceduresExecute or support system-level testing and data analysisConduct testing on both the system and subsystem levels, including bench tests, simulations, and clinical evaluations, engineering prototypes etc.Ensure test reports and integration reports are prepared to document results, findings, and compliance statusSupport issue investigation, root cause analysis, and corrective actions Lifecycle and Change ManagementManage engineering change orders (ECOs) and lifecycle updates through digital platforms such as Oracle and VeevaEnsure accurate documentation, review coordination, and timely implementation of approved changesSupport configuration control by ensuring system documentation reflects released and implemented changesCollaborate with cross-functional teams to assess system-level impact of changes on requirements, verification, and compliance Cross-Functional & Compliance SupportWork closely with hardware, software, firmware, mechanical, quality, and regulatory teamsSupport risk management activities, including hazard analysis and FMEA updatesAssist with design control and compliance documentation as requiredSupport internal and external audits, reviews, or assessments as needed Risk Management:Support hazard analysis and risk assessments (e.g., Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA)) to identify potential risks. Work to minimize risks through design controls, redundancy, and safety mechanisms.Qualifications:Bachelor's degree in electrical engineering or related field; advanced degree preferred.5+ years of experience in system engineering within the medical device industry, with a focus on complex electro-mechanical devices.Demonstrated success as an engineering team member in the architecture, system level design, integration and verification of complex electro-mechanical devices.Experience with complex electromechanical systemsStrong understanding of system verification and validationHands-on experience with system integration, testing, and troubleshootingExperience of utilizing the requirement management tools such as Helix, Jama etc.Development experience in at least one or more of the following engineering disciplines is required: software, mechanical, electrical, optics, and should possess knowledge of advanced theories, concepts, principles, and processes.Understanding of regulatory standards and requirements, particularly 60601-1, 60601-2, 60601-1-6 and other relevant compliance and safety standards, preferred.Ability to work effectively across different functions and with external partners to drive project success.Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.Detail-oriented with strong analytical and problem-solving abilities