Systems Engineer – Medical Devices

Systems Engineer – Medical DevicesContract Duration - 12months/W2/C2CWe are seeking a Systems Engineer to support the development and lifecycle management of advanced critical-care medical devices, including systems used for acute kidney care and CRRT.Key ResponsibilitiesDrive systems engineering activities from feasibility and product development through verification, validation, and lifecycle management.Translate clinical/user needs into system requirements, design concepts, and product solutions.Manage requirements, traceability, risk management, DHF, system integration, V&V, and design changes.Identify technical risks, perform impact assessments, and develop mitigation strategies.Collaborate with software, electrical, mechanical, quality, regulatory, manufacturing, and clinical teams.Ensure compliance with FDA, ISO, and IEC design-control requirements.RequirementsBachelor’s/Master’s degree in Electrical, Software, Mechanical, Biomedical Engineering, or related field.3+ years of relevant systems engineering experience.Experience with medical devices or other regulated/safety-critical products.Strong experience with system requirements, risk management, integration, verification, and validation.Knowledge of SysML/UML and requirements management tools.DOORS or Jama experience preferred.Experience with connected/software-enabled and electro-mechanical systems preferred.Familiarity with Teamcenter, TrackWise8, JIRA, or ALM is a plus.Strong analytical, communication, problem-solving, and cross-functional collaboration skills.Preferred BackgroundMedical devices, ICU/critical care, dialysis/renal therapy, CRRT, infusion pumps, ventilators, patient monitoring, or other FDA-regulated products.