*recent college grads in biomedical/bioengineering (or equivalent) are invited to apply.
The System Integration Test Engineer will work side-by-side with Systems, Hardware, Firmware, and Software Engineers in the development and validation of new molecular diagnostic platforms. Specifically, the Test Engineer will design, develop, and validate test methods and protocols for performance verification and validation of hardware and consumables designs, and will execute testing, perform data analysis, and provide feedback to the team regarding system performance relative to defined metrics. Responsible for compliance with FDA, ISO, and internal Quality System requirements.
· Bachelor’s Degree plus two years of progressive experience in the fields of Biological Engineering, Biomedical Engineering, Bioengineering, Mechanical Engineering, Materials Science, Physics, or a related field.
Required Knowledge and Skills:
· Experience designing, validating, executing, and documenting test methods and protocols, including Design Verification and Validation testing
· Root cause failure analysis and hands-on troubleshooting
· Data analysis using MiniTab, Origin, Mathematica, Matlab, or equivalent software. Experience with basic statistics.
· Hands-on experience building and testing hardware (mechanical, optical, electrical) instrumentation, consumables, and systems
· Clear and concise technical writing for the documentation of experiments and test reports
· Excellent oral and written presentation skills for clear communication to highly cross-functional teams
· High degree of organization and efficiency in multi-tasking to support concurrent project priorities
· Demonstrated experience in an FDA/ISO regulated environment
· Experience with PCR (Polymerase Chain Reaction) and PCR-based testing systems
· Experience working with optical systems
· Machining skills (mill, lathe, CNC, 3D printing)
· Solidworks, pro-E, or other CAD design software
· Knowledge of optics and optical systems
· Macro coding (e.g. Excel), C, C++, Python, or other