Title: Systems Engineer
Location: On-site in Baltimore, MD
Terms of Employment
Full-Time, Permanent
This position is fully onsite in Baltimore, MD 21230 Monday-Friday, normal business hours.
Overview
Our 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.
Responsibilities
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.
Required Skills & Experience
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.
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