Sr Sys Integration_Test Eng
On-site · Bethlehem, Pennsylvania, United States
Job Summary
The Senior Systems Integration and Test Engineer will lead the functional integration of hardware, software, firmware, and optical subsystems for a cohesive robotic microscope platform, own the Formal System Verification activities, and drive testing from prototyping through system hardening. Responsibilities include developing and executing iterative tests, characterizing performance at the intersection of optical quality, robotic movement and computer vision, coordinating verification with cross-functional teams, building test fixtures and automated test scripts (Python, MATLAB, LabVIEW), collaborating with Validation and RMF activities, and supporting regulatory submissions (FDA/MDR) while ensuring traceability from requirements to verification. The role emphasizes system-level requirements, risk management, DFMEA/UFMEA input, and Design for Testability feedback during design reviews, with a preference for candidates experienced in medical imaging, optical concepts, and robotics within a clinical environment.
Required Qualifications
- Typically requires a minimum of 5 years of related HW/SW/System/Integration experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD with 2 years experience; or equivalent experience.
- Experience in medical imaging and scientific imaging technologies
- Experience in medical device development
- Experience with optical concepts, optical design and camera technology
- Expertise in writing and executing formal System Verification protocols for medical devices
- Expertise with scripting languages for test automation and data analysis (Python, MATLAB, LABView)
- Experience with robotics, motion control, and optical systems
- Experience in Requirements review for testability
- Experience troubleshooting complex electro-mechanical assemblies in-person and using debug logs
- Knowledge of testing for IEC 60601-1 and EMC compliance
- Working knowledge of Quality Management Systems
- Workling knowledge of Risk Management
- Broad knowledge of engineering concepts (EE, ME, SW) and how they interact in a system
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