Kordell T.

Experience

• Technical Program Manager iSono Health · Full-time Jun 2023 – Present 2 yrs 6 mos San Francisco, CA, United States
• Biomedical Engineer Lumina Medical · Contract Mar 2023 – Present 2 yrs 9 mos Los Angeles, CA, United States • Developed and designed preliminary electrical design for motorized anorectal dilator device intended for the treatment of rectal stenosis
  
  • Successfully awarded NIH grant for development of force-sensing anorectal dilation device
• Human Factors Engineer SafeBeat Rx · Contract Feb 2023 – Present 2 yrs 10 mos San Francisco, CA, United States • Planned, coordinated, and managed a 20+ participant human factors/usability validation study for a software-as-a-medical-device (SaMD) product
  • Reviewed and refined human factors (HF) documentation to ensure compliance with FDA, IEC 62366-1, and ISO 14971 standards for SaMD
  • Conducted User Research Risk Analysis (URRA) to identify potential use errors and mitigate usability risks throughout the product lifecycle.
  • Developed test protocols, moderator guides, and data collection tools to capture critical usability metrics and qualitative feedback
  • Analyzed usability study results to inform design changes and risk mitigations prior to regulatory submission
  • Collaborated cross-functionally with design, software, and regulatory teams to integrate human factors insights into product requirements
  • Ensured traceability of HF requirements and findings into the Design History File (DHF) to support regulatory submissions
• Technical Project Manager Axonics, Inc. · Full-time Jan 2024 – Mar 2025 1 yrs 2 mos Irvine, CA, United States • Conducted successful usability studies for sacral neuromodulation system, including trial systems and therapies
  • Successfully achieved regulatory approvals for packaging validations of new products and new packaging configurations for Class III surgical tool kits and implantable devices
  • Lead project manager for the establishment and validation of the manufacturing production lines and operations at a new facility expansion
  • Lead packaging project manager managing DoE and packaging validation studies including transit distribution testing, shelf stability studies, and packaging equipment validations for foramen finder and implantable sacral nerve stimulator devices
• Electrical Engineer EverSafe Sensory LLC · Contract Jul 2023 – Jun 2024 11 mos OH, United States • Designed and integrated prototype sensory device into a single PCBA, featuring force-sensing trigger for an oral chew device
  • Performed verification testing on charging and device sensory performance
• Electrical Engineer Galaxy Therapeutics, Inc. · Contract Jul 2022 – Mar 2024 1 yrs 8 mos Milpitas, CA, United States • Achieved FDA IDE approval of the SEAL Detach Handle as electrical engineer consultant
  • Defined and created the product specification requirements, test verification protocol, instructions for use manual, and risk management file of the first and second generation SEAL Detach Handle
  • Managed the successful completion of EMC testing and electrical safety testing of the first and second generation SEAL Detach Handle
  • Created usability engineering file for a neurovascular embolization detachment handle device
  • Developed a suitable test fixture to perform design verification testing on the detachment component of the neurovascular embolization system
• Project Engineer PFM Medical, Inc. · Full-time Mar 2021 – Jan 2024 2 yrs 10 mos Carlsbad, CA, United States • Designed, developed, commercialized, and sustained a product portfolio of over 50 vascular access and drainage system products across three continents
  • Designed and developed the ASEPT Power Flush Adaptor drainage accessory device, as the core team leader, managing the project through medical device design control processes
  • Designed and developed next-generation PrimePICC Catheter and procedure insertion kit
  • Achieved 510(k) clearance for an indwelling drainage catheter as the engineering project lead
  • Successfully managed the development of the JetCan Pro Safety Huber Needle infusion set device, achieving EU MDR clearance and 510(k) submission
  • Performed human factors and usability assessments and engineering files for drainage, infusion set, and vascular access products
  • Designed and developed medical device product requirements and qualifications, including preliminary manufacturing drawings, risk management assessments, and total product specifications for drainage and vascular access products
  • Performed sustaining engineering activities, such as qualifying components for medical device assemblies and procedure kit components
  • Created bill of materials, lot history record documents, manufacturing work instructions, label and packaging specifications, and instructions for use for a wide variety of medical device kits
  • Conducted engineering experiments, completed performance testing of assemblies and components, and developed test methods, fixtures, and rapid prototypes for feasibility testing
  • Developed standard operating procedures related to statistical trend analysis methods to be used for root cause investigations, statistical process monitoring and control, and nonconformance detection
• Process Engineer Fluxergy, Inc. · Full-time Jul 2019 – Mar 2021 1 yrs 8 mos Irvine, CA, United States • Successfully guided department through ISO 13485-MDSAP audit and registration by creating department SOPs, manufacturing work instructions and travelers, and maintaining process controls by designing quality inspections of assemblies
  • Achieved CE mark for the Fluxergy Device Analyzer
  • Assisted in the development of prototype Python and C++ test scripts for temperature-sensing subassembly modules to update and configure sensor emissivity factor
  • Designed and modified manufacturing processes, procedures, and production layouts for assemblies, equipment installation, and material handling for bioassay analyzers (IVD)
  • Measured device assembly process with Minitab and use statistical methods, data, and other metrics to drive business decisions for production operations
  • Assisted R&D and provide engineering support with hardware debugging, device troubleshooting, testing components, and evaluating new methods of verification for the device analyzer
  • Managed device production team and support projects, work procedures, and training activities
• Biomedical Engineer Siella Medical · Full-time Jan 2019 – Jan 2020 1 yrs Irvine, CA, United States • Performed repairs, preventative maintenance tests, calibration of pump sensors, and hardware assembly of B. Braun Infusomat Space Series pumps (syringe and volumetric models), Curlin 6000 and 4000 infusion pump models, Alaris 8100 series pumps, Covidien Kangaroo enteral feeding pumps, and TOCO fetal transducers by disassembling, soldering, and troubleshooting board components
  • Support month-to-month company gross profit of $100,000+ by processing service work orders that prioritized shorter lead time repair of equipment, while ensuring equipment work is completed within 7 days
  • Contribute to the defective device return rate of under 5%
• Junior Project Engineer Tesla Energy Engineering, Inc. · Part-time Oct 2018 – Jan 2019 3 mos Orange, CA, United States • Drafted solar generation proposals using Energy Toolbase for residential and commercial systems measuring between 36kW and 2MW
  • Reviewed preliminary drawings, single-line diagrams, and materials take-offs for site plans and projects
• Manufacturing Engineering Intern Smart Electronics and Assembly, Inc. · Full-time Jun 2015 – May 2017 1 yrs 11 mos Anaheim, CA, United States • Managed a manufacturing transfer project of hardware and printed circuit board assemblies, verifying all documentation and work instructions were fulfilled per manufacturing standards and identified missing components in a gap analysis
  • Generated technical documentation including assembly work instructions, quality control procedures, and definitions of manufacturing requirements and standards per JST and MIL-SPEC
  • Assisted in assembling cables and harnesses, generated technical reports, and performed QC and AOI inspection on circuit board projects, increased process output efficiency by performing time studies of various production procedures