Systems Engineer

Design Control & Regulatory Documentation Maintain and organize Design History Files (DHF) in compliance with FDA 21 CFR 820 and applicable standards for 510(k) submissions Develop and manage a comprehensive requirements traceability matrix (RTM) spanning user needs, product requirements, and subsystem specifications Author and execute Verification & Validation (V&V) plans, protocols, and reports Perform 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 compliance Support Corrective and Preventive Actions (CAPA) investigations and documentation arising from V&V activities

System Verification, Testing & Experimental Design Design and execute experimental strategies to evaluate performance of engineering and biological subsystems Define clear acceptance criteria aligned with product requirements and intended use Develop detailed test protocols, test cases, and verification procedures with strong traceability to requirements Conduct experiments, ensuring accurate data collection, logging, and traceability in compliance with quality standards Analyze test data and document results in technical reports, including conclusions and recommendations Collaborate with cross-functional teams to review test strategies and results

Calibration, Manufacturing Transfer & Process Development Develop and validate calibration procedures for instruments and subsystems Ensure calibration processes are robust, repeatable, and transferable to manufacturing technicians Define and document acceptance/rejection criteria for instruments and subassemblies Provide training and documentation to support manufacturing and quality teams Support design transfer activities, ensuring smooth transition from development to production.

Our client is looking for a highly motivated and detail-oriented Engineer to lead testing and verification efforts for the Novel Dx device., Background 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 data 3+ 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.