Systems Engineer (Biomedical/Robotics/Electromechanical)

Terms of EmploymentFull-Time, PermanentThis position is fully onsite in Baltimore, MD 21230 – Monday-Friday, normal business hours. OverviewOur client is looking for a highly motivated and detail-oriented Engineer to lead testing and verification efforts for the Novel Dx device.In this role, you will operate at the interface of Systems Engineering and assay performance, developing calibration protocols for manufacturing and driving Clinical Verification and Validation (V&V) activities. You will design and execute test strategies to ensure the device consistently meets performance and regulatory requirements.ResponsibilitiesDesign Control & Regulatory DocumentationMaintain and organize Design History Files (DHF) in compliance with FDA 21 CFR 820 and applicable standards for 510(k) submissionsDevelop and manage a comprehensive requirements traceability matrix (RTM) spanning user needs, product requirements, and subsystem specificationsAuthor and execute Verification & Validation (V&V) plans, protocols, and reportsPerform and document risk management activities including hazard analysis, FMEA, and risk mitigation strategies (per ISO 14971)Lead and facilitate cross-functional design reviews, ensuring design control complianceSupport Corrective and Preventive Actions (CAPA) investigations and documentation arising from V&V activitiesSystem Verification, Testing & Experimental DesignDesign and execute experimental strategies to evaluate performance of engineering and biological subsystemsDefine clear acceptance criteria aligned with product requirements and intended useDevelop detailed test protocols, test cases, and verification procedures with strong traceability to requirementsConduct experiments, ensuring accurate data collection, logging, and traceability in compliance with quality standardsAnalyze test data and document results in technical reports, including conclusions and recommendationsCollaborate with cross-functional teams to review test strategies and resultsCalibration, Manufacturing Transfer & Process DevelopmentDevelop and validate calibration procedures for instruments and subsystemsEnsure calibration processes are robust, repeatable, and transferable to manufacturing techniciansDefine and document acceptance/rejection criteria for instruments and subassembliesProvide training and documentation to support manufacturing and quality teamsSupport design transfer activities, ensuring smooth transition from development to production.Required Skills & ExperienceBackground in biomedical, systems, or electrical/mechanical engineering which translates into cross functional ability to work with electronics/firmware and able to understand biological systems to run assays on a microfluidic device and interpret the data3+ years of relevant industry experience working with Medical Devices(IVD preferred) Familiarity with FDA design controls, ISO 13485, and risk management standards Strong systems thinking and communication skills to work across hardware, software, and biological interfaces.Note:For this role, our ideal hire would be someone who can set up, calibrate, operate, and debug the Dx instrument, which is an electromechanical device involving motors and pumps. This individual should be able to develop a deep understanding of the system and contribute by writing test protocols to support our Verification and Validation efforts, as well as executing those test plans.We are looking for a Systems Engineer with a strong background in robotics/electronics.