Cassie Ng

Education

Northeastern University, Boston, MA

Bachelor/Master of Science in Bioengineering, Biomedical Devices and Bioimaging Concentration

Minor in Mathematics

GPA: 3.74/4.00

Honors and Awards: Dean’s List

Job Experience

Portal Instruments | Cambridge MA

Senior Verification Test Engineer

• Designated project manager for Preclinical team – conducted sprint reviews and planning through utilization of Jira
• leading meetings, updates to management/communication*
• Planned, prepared, and worked with a CRO to execute the company’s first human cadaver study
• Led a team of 4 through all ex-vivo testing activities including injection performance, injection depth, and comparison to industry standards of care to support needle-free technology
• Assisted in designing and conducting an experiment to verify device’s ability to inject high-viscosity solutions, enhancing needle-free product functionality and market potential
• worked w 3 different clinical models*
• Spearheaded the recruitment, training, and mentorship of co-ops within the Preclinical team, fostering strong team culture
• Implemented a lab facility scheduling and booking system to optimize resource allocation and minimize personnel congestion, ensuring efficient utilization of lab space
• Supported regulatory Pre-Sub and Pre-IND submission packages*

Verification Test Engineer

• Designed and executed ex-vivo and in-vivo tissue tests using custom-built devices
• Prepared and executed test protocols, collected and analyzed data, wrote detailed test reports
• Tested injections with optical micrometer, Instron, and force plate aiding Design Verification and independent studies
• Performed test method validations on test systems using Crossed Gage R&R studies in Minitab
• Assisted in developing methodology to measure injection depth using gels, synthetic tissue, and ex-vivo tissue
• Prepared pre-clinical documents and summarized test data to mitigate device error for animal studies
• Drafted a test assembly design document and IQ/OQ procedure for an optical micrometer test assembly
• Executed Quality Control and Assurance activities to support development efforts

Clinical Engineer Co-op

• Managed and provided technical assistance to pre-clinical studies
• Analyzed test data with R/RStudio using multi-linear regression techniques
• Developed injection testing methodology for research purposes while working alongside cross-functional teams
• Assembled and tuned custom apparatus to test and develop fluid velocity profiles using Copley Motion Explorer
• Catalogued and analyzed DICOM data for depth of drug injection in porcine tissue following a GLP animal study
• Filled and stoppered over 4,000 cartridges using a benchtop stoppering fixture for R&D and Design Verification

Hologic | Marlborough, MA

Sustaining R&D Engineer Co-op

• Recovered 200 missing documents in gap analysis for med. device compliance with REACH/RoHS regulations
• Drafted a procedure to outline proper documentation of REACH and RoHS declarations in internal system
• Communicated with vendors to obtain missing certifications of conformance for REACH and RoHS regulations
• Updated over 4,200 product IFUs, manuals, and external labels to meet requirements related to Brexit
• Investigated missing product verification reports to provide evidence for claims made in clinical evaluation reports
• Completed tensile testing for medical device disposables as it related to real time aging requirements

Engineering Projects

Automated Phototherapy Integration into Neonatal Incubator | Bioengineering Capstone

• Optimized existing incubator design for Breegi Scientific to incorporate blue-light LED functionality
• Developed and executed testing protocols for LED array and incubator temperature measurement
• Created and executed testing protocols for LED array wavelength verification and intensity testing
• Assisted coding failsafe mechanisms for incubator overheating and LED malfunction on an STM board

Heart Rate Variability (HRV) Device | Design of Biomedical Instrumentation

• Created, validated, and verified an HRV device intended to identify effectiveness of anti-depressive treatment using an Arduino and MATLAB’s Simulink to calculate one’s root mean square successive difference (RMSSD)

Research and Business Proposals | Biomaterials, BioE Products/Tech Commercialization

• Designed a research plan and experiments proposing a PLA-based biodegradable food wrap through variation of copolymer content and film thickness
• Presented a business plan summarizing the technology, market potential, and free cash flow analysis