About this opportunity
DeepSight Technology lists this Senior Systems Engineer opportunity in santa clara, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Systems EngineerDeepSight Technology Inc. is an early-stage, pre-commercial medical device company with a vision for Physical AI -scaling advanced multimodal sensing technologies so clinicians can see more, sense more, and guide procedures with greater precision and confidence. Our vision starts with developing a breakthrough platform combining acousto-optic sensing technology and ultrasound imaging.DeepSight Technology is seeking a Senior Systems Engineer with a strong focus on Test Development and System Integration to support the development of our next-generation medical imaging platforms. This role is critical to ensuring that system-level requirements, risk controls, and verification strategies are effectively translated into robust, traceable, and regulatory-compliant test solutions.In this role, you will be responsible for test measurement systems design and development spanning the full hierarchy of the product hardware. Your focus will include system engineering principles to ensure successful product V&V, which includes test system requirement generation, verification planning, test architecture development, and integration efforts, working across hardware, software, clinical, quality, and regulatory teams. You will play a key role in driving high-quality design outcomes by using risk-based testing and system engineering best practices.ResponsibilitiesDevelop and own system-level test strategies, including verification plans, test protocols, and acceptance criteria aligned with design inputs, and risk controlsWork closely with subject matter experts to develop test methods, documentation, and perform verification of custom test measurement systemsPrepare and execute third party standards testing in conjunction with hardware and software teamsLead the development of risk-based test coverage driven by Hazard Analysis, Risk Assessments, and DFMEAsEnsure test methods effectively verify safety and performance, requirements at the system, subsystem, and component levelsSupport development and execution of verification and integration testing, including hands-on testing where appropriateLead and coordinate system integration activities, ensuring hardware, software, algorithms, and clinical workflows function together as intendedIdentify, diagnose, and resolve integration issues across disciplines, working closely with design, software, and test teamsEnsure test development and integration activities align with design control requirements for regulated medical devicesContribute to failure analysis, root cause investigations, and corrective actions as neededCollaborate with Product Management, Clinical, Hardware, Software, Quality, and Regulatory teams to ensure test and integration efforts meet product and compliance needsCommunicate test strategy, results, and risks clearly to both technical and non-technical stakeholdersRequired QualificationsBS in Electrical Engineering, Biomedical Engineering, or a related technical field6+ years of experience in medical device or medical imaging product developmentDemonstrated experience with test protocol development, execution, and traceability for regulated productsStrong background in system integration, verification, and risk-based testingSolid understanding of relevant standards and regulations, such as: ISO 13485, ISO 14971, IEC 60601 (system and subsystem level), IEC 62304 (software lifecycle, as applicable).Experience working within formal Design Control processesExcellent communication, documentation, and cross-functional collaboration skillsPreferred QualificationsMS in Electrical Engineering, Biomedical Engineering, or a related fieldExperience in medical imaging systems (Ultrasound strongly preferred)Experience supporting FDA submissions and regulatory auditsAbility to write or review test automation, test scripts, or control code (e.g., Python, C/C++)Prior experience working in Agile or hybrid development environments
Worksite address
santa clara, CA, 95050, US
Who can apply
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