Seth Judson Email & Phone Number

Goleta, California, United States

Oversaw the clinical, human-factors, and Verification process for next generation exoscope for use in Neurosurgery. Worked with engineering and marketing teams to Maintained verification and sustaining requirements on class 1 medical exoscope, for continued manufacturing and sale to market.Developed Human Factors Process for FDA/MDR Class 2 device submittal according to FDA recommended processes and IEC 62366. Assisted in animal studies for prototype review and for validation of capital medical devices for use in the OR.provided risk management documentation and verification testing according to 14971 and 60601 ed3.2

Boston, Massachusetts, United States

Brought clinical devices from early design phase to initial first in Human Clinical Trial Phase, Assisting in creating and documenting devices and systems. Through this first of its kind OCT systems used in novel diagnostics are being tested around the globe. Brought Clinical Device from Early Design phase to initial first in Human Clinical Trial Phase.• Documented and manufactured safety console for high power laser in use for OCT clinical research and collection of biopsy samples, advancing ability to better diagnose esophageal disease. Worked to layout and fabricate critical safety components.

Greater Boston

Designed systems and probes for use in Human Gastrointestinal and Pulmonary system. Created, reviewed, and maintained drawings, FMEA, BOM, Fabrication SOPs, IFUs, and QA Testing Schemes to improve clinical research devices. Manufactured Optically Guided Microbiome sampling devices for testing in clinical research. • Designed, qualified, and accepted devices with appropriate design controls through use of bench top in vitro studies and animal studies, ensuring safety and function in clinical microbiome studies.• Developed and implemented studies to determine efficacy and safety of designed devices using metrics, including histological damage, optical transmission and clarity, and destructive force.

Greater Boston Area

Used additive manufacturing for rapid prototyping, clinical fabrication, and testing of microbiome sampling devices.• Collaborated with regulatory team to develop failure modes and effects analysis documentation submitted to animal and human study regulatory board for acceptance and associated testing to prevent severe failure.• Conducted and led In Vivo and Ex Vivo swine studies, including extraction and use of swine GI, Pulmonary, Musculature, Skeletal, and Cardiovascular tissue to advance safety and preliminary research.

- Wrote SOPs to maintain Good Manufacturing Procedures in Production-Trained Technicians in SOPs

United States

Researched in Ge Wang CT Lab specializing in multi-modal imaging and x-ray uses beyond CT.• Characterized solenoid for use in x-ray pulse generator to control the dose in experiments integrating particles and living tissue, measuring pulse delay, width, and amplitude.• Fabricated models and sample holders to aid in work of nanoparticle characterization through spectral micro CT, spectroscopic imaging, and MRI.• Understood effects of X-rays through the investigation of patch clamp solutions for use on a custom setup to obtain measurements of cell electrophysiology.

Arlington, Vt

Worked at Contract Manufacturer specializing in precision and protected IP. Completed installation qualifications and preventative maintenance for customer and company equipment to track plant requirements and ensure proper use of equipment on the line.• Created and organized engineering documents for accurate creation of assembly lines and reduction of risk by 30%. • Produced layouts for manufacturing process of Sterile Medical Filter in ISO class 8 clean room, reducing floor use 20%.• Developed standard operating procedures (SOPs) for fabrication of high-complexity, low-yield production line, maintaining Good Manufacturing Procedures in production.

Bachelor Of Engineering (B.E.), Biomedical/Medical Engineering

Activities and Societies: Alpha Phi Omega

Education record

Activities and Societies: Sharon High School Theatre Company Ultimate