Sr. Systems Engineer (Medical Devices)

Sr. Systems Engineer (Medical Devices) Pleasanton, CA (Onsite) 6+ Months Contract | 8:00 AM – 5:00 PMOverviewWe are seeking an experienced Sr. Systems Engineer with a strong background in medical device software to support system design, requirements development, and regulatory compliance in a fast-paced Agile environment.Key ResponsibilitiesLead requirements elicitation, decomposition, and traceabilityDevelop system/software architecture (SysML)Perform risk analysis (dFMEA) and create trace matricesLead technical design reviews and author high-quality documentationCreate development plans and trade-off analysesCollaborate cross-functionally and support Agile project executionRequired Qualifications5+ years of systems engineering experienceExperience in medical device industry (mandatory)Strong expertise in requirements engineering & management toolsKnowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, EU MDRExperience working in Agile environmentsStrong communication and ability to lead/coordinate teamsEducationBachelor’s degree required