Systems Engineer (Biomedical/Robotics/Electromechanical)

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 stan...