Cassandra Saleira

• Designed medical electrical device for high frequency electrosurgery with ultrasound system • Focused on electrical design, system integration, and optimization • Designed ultra-flexible braided reinforced catheter for electrosurgical medical device application • Designed electrical subassembly, including flex PCB and over-molded plug for HF device with multiple moving internal parts • Developed product from feasibility to clinical trials to DFM for commercial release phases • Successfully ensured system compliance with IEC 60601 series standards and EMC requirements • Performed usability engineering design compliant with IEC 60601-1-6 and IEC 62366-1 • Collaborated with quality department to assemble risk management file consistent with ISO 14971 • Performed and maintained DFMEA risk management documentation for Gen1 and Gen2 device designs • Produced engineering documentation in line with regulatory body requirements (NSAI, Health Canada, & FDA) • Performed DOE and factorial experiments with ex-vivo tissue and bench-testing to improve system efficiency • Performed engineering design analysis through testing, numerical methods, mathematical modeling, and statistical analysis techniques • Produced technical engineering documents for protocols, test methods, manufacturing work instructions, reports, presentations, and justifications • Designed in-house professional quality labels and graphics for IFU, regulatory documentation, and marketing use

• Designed medical electrical device for high frequency electrosurgery with ultrasound system • Focused on electrical design, system integration, and optimization • Designed ultra-flexible braided reinforced catheter for electrosurgical medical device application • Designed electrical subassembly, including flex PCB and over-molded plug for HF device with multiple moving internal parts • Developed product from feasibility to clinical trials to DFM for commercial release phases • Successfully ensured system compliance with IEC 60601 series standards and EMC requirements • Performed usability engineering design compliant with IEC 60601-1-6 and IEC 62366-1 • Collaborated with quality department to assemble risk management file consistent with ISO 14971 • Performed and maintained DFMEA risk management documentation for Gen1 and Gen2 device designs • Produced engineering documentation in line with regulatory body requirements (NSAI, Health Canada, & FDA) • Performed DOE and factorial experiments with ex-vivo tissue and bench-testing to improve system efficiency • Performed engineering design analysis through testing, numerical methods, mathematical modeling, and statistical analysis techniques • Produced technical engineering documents for protocols, test methods, manufacturing work instructions, reports, presentations, and justifications • Designed in-house professional quality labels and graphics for IFU, regulatory documentation, and marketing use

• Developed and improved performance of the electrosurgical device through design, testing, and analysis • Performed engineering analysis through Solidworks modeling, FEA, mathematical modeling, statistical analysis, and risk management (DFMEA) • Planned and executed entire verification phase for pre-clinical electrosurgical medical device • Designed test fixturing and test methods for all verification phase activities • Developed and facilitated testing for feasibility, development, verification, and validation project phases • Tested and analyzed device for use failure cases, safety, efficiency, reliability, efficacy, and system compatibility • Tissue ablation and coagulation testing and design experience, including development of tissue simulants • Redesigned electrodes and refined system settings to improve ablation size and efficiency • Developed model for electrical system design during ablation through range of system impedance • Determined cause of failure for high frequency leakage current and modified electrical system design to mitigate risk • Produced technical engineering documents and deliverables including protocols, test methods, plans, reports, and presentations • Obtained FDA 510(k) and Health Canada FHU clinical trial device approvals • Successfully ensured system compliance with quality requirements and specifications, including IEC 60601 series, ISO 10993 series, and ISTA 3A

• Supported product development of medical devices by conducting design feasibility and development testing • Testing and DOE experience with tissue simulants, ex-vivo, and in-vivo • Engineering analysis experience through compiling and reporting test data in formal reports and presentations • Solidworks modeling and revision control experience with PDM • Prototyping, device fabrication, and manufacturing process improvement experience

Aid community members with automotive servicing, system diagnosis, repair, and general advice. Design and develop custom mechanical, electrical, and computerized systems for various automotive applications.

• Surveyed storm water flow on campus, input data into ArcGIS, and analyzed existing storm water management systems • Conducted an environmental impact survey and quantified storm water runoff to verify the efficiency of existing bioswales and drainage systems • Project findings earned the college $27,300 in annual tax credit

• Student leadership position • Coordinate entertainment based campus events and opportunities for students • Design advertisements and market events

• Student leadership position • Coordinate diverse campus events and opportunities for students • Design advertisements and market events