Currently on the tail end of a 1 year sabbatical. In the meantime, I have been contracting part-time with Infraredx as subject matter expert for the catheter R&D team, ISO 13485 auditor, and to collaborate on new product development and sustaining engineering activities.

- Designed a unique injection molded mechanism for single-handed connection and disconnection of complex neuro-OCT catheter (collaboration with Gentuity, a Nipro company).- Redesigned and prototyped opto-mechanical spectroscopy meter for dialysis machines (collaboration with Nipro) reducing size, cost, and improving manufacturability.- Met with doctors and attended PCI procedures in Japan to identify customer needs for future projects.- Developed and validated a new test method to quantify rotational distortions in ultrasound images.- Led development and qualification testing of torque transmission cables (0.020”-0.040” OD).- Developed, validated, and implemented changes to the NIRS+IVUS torque transmission which resulted in a 50% reduction of the occurrence and severity of the distortions.- Investigated catheter ultrasound artifacts, developed, validated, and implemented corrective and preventive actions for 5 separate root causes. Ultimately reduced the customer complaint rate by 12%.- Re-wrote usability engineering procedure and validation protocols per latest standard.Coordinated biocompatibility, shelf-life and ship testing with external vendors.- Led catheter validations to support extended shelf-life.- Participated in FMEA updates and Design Reviews for capital equipment, disposable, and software.- Trained and mentored junior engineers, technicians, interns and co-op students (task specific).- Conducted periodic internal audits (certified ISO 13485:2016 lead auditor).

- Collaborate with all functional areas to promote project success- Develop product and process requirements and specifications for hardware and software- Build and modify fixtures and prototypes- Coordinate repair and recalibration of engineering tools- Train and provide direction to college interns and co-op students

- Collaborate with all functional areas to promote project success- Develop product and process requirements and specifications for hardware and software- Build and modify fixtures and prototypes- Coordinate repair and recalibration of engineering tools- Train and provide direction to college interns and co-op students- Participate in the preparation of an FDA Pre-submission (device description and component verification)- Interim project manager for 5 months- Secretary during FDA audit- Responsibilities and activities listed under Engineering Intern

- Design, execute, and document feasibility, acceptance, and verification tests- Troubleshoot product and process design (hardware and software)- Analyze and interpret test results- Prepares and shares timely reports and findings of experiments- Participate in and document project activities like FMEA and Design Reviews- Automate data acquisition and processing systems for feasibility testing- Manage own time and activities to meet project deadlines- Work effectively with other functional groups (internal and external) to meet project goals

- Characterization of polymer's lower critical solution temperature using dynamic light scattering- Participated in weekly lab presentations and meetings- Presented findings at UCSB's summer intern poster symposium

- Performed human pre-clinical studies. Responsibilities included stocking the clinic, receiving the subjects, on-site screening, and performing the actual studies which included monitoring blood glucose and documenting results every 15 min for up to 4 subjects for multiple hours. Depending on the blood sugar readings I had to recommend light walking, administration of insulin, or snacking to achieve a full set of data points.- Automated laser diode testing using LabVIEW and subsequently qualified incoming laser diodes.- Recruited and screened volunteers for pre-clinical studies through phone calls. I was also in charge of managing the database with the subject's information.- Led the effort in outsourcing Grove Instruments’ in vitro studies. I identified and contacted the candidate company. I also prepared the project outline for the studies.- Determined feasibility and regulatory requirements for Grove Instruments to be able to be able to administer Glucagon doses.- Prepared advertising proposals for NEIRB approval

- Revision of SOPs relating to CAPAs and NCMR reporting and tracking- Coordinate CAPA and NCMR tracking system- Train new Engineers and Managers from different functional areas to track and report CAPA and NCMRs - Secretary during internal and external audits- Reviewed IQ/OQ/PQ reports for approval- Initiated document change process for out of date IQ/OQ/PQs- Perform internal audit of manufacturing lines