> Technical lead for cross-functional team of 5 to setup Hydroxyapatite (synthetic bone) production line at sister facility under a quality system conforming to ISO13485 requirements, which was completed 2 months ahead of schedule and under budget. - Designed a new facility layout to optimize the existing footprint (approx. ¼ scale of existing facility) and scaled all new production equipment, while meeting existing demand of about 2000 kg per year and accommodating for future growth up to 5000 kg per year. - Updated roughly 120 procedures utilizing detailed instructions to reduce dependence on undocumented knowledge. - Authored the Validation Plan, which included 23 validations (IQ, OQ, PQ, pilot) and 8 new process FMEAs. - Worked with QA to develop requirements for and to document calibration plan, maintenance schedule, and to improve data gathering and storage for process monitoring. - Reported progress to senior management including timeline, risks and mitigations, and budget.> Led DOE to improve plasma coating method and its test method, which informed new process controls and added previously unknown information about the process and product. > Developed a cleaning process validation strategy covering roughly 1000 parts, and created a formalized methodology based on part geometry and materials which was adopted by our parent company to adapt to future cleaning validations at other 3 sites.> Wrote rework and disposition instructions for Nonconformance Reports and investigated CAPAs for manufacturing issues.> Contributed to cGMP audits including MDSAP, FDA, Anvisa (Brazil), and TUV (European Union).

MRI Development Using Software-Defined Radios> In Press: gr-MRI: A Software Package for Magnetic Resonance Imaging Using Software Defined Radios – Featured on the Cover of the Journal of Magnetic Resonance [JMR] Vol 270 and has been on the “Most Downloaded” list for over 2 years.> Developed intuitive and interactive MRI system based on open-source software and commercially available software defined radios at 10% of the cost of the next available model.> Created flexible, robust “stock” imaging sequences, automatic hardware calibration scripts, and SDR-MRI specific libraries using C++ and Python, which were offered to the research community as open-source.> Wrote a detailed user manual with instructions for hardware modifications, general use of the stock sequences, and how to modify existing sequences or create new sequences.> Selected to present work in the “Novel Technical Development” section of the May 2015 conference of the International Society for Magnetic Resonance in Medicine (ISMRM), at the 2015 New England Workshop on Software Defined Radio, and at the 2016 ISMRM conference.RF Spatial Encoding for Gradient-Free MRI> Developing novel RF spatial encoding technique using frequency-swept pulses that reduce the bulk, and noise created by traditional gradient systems.> Designed and built RF coils, coil housing, tuning and matching circuits, active detuning system, and encoding pulse sequences.

> Developed and built small, low field permanent magnet Nuclear Magnetic Resonance (NMR) scanner for use and replication in undergraduate course.> Designed and debugged RF signal pathway for NMR scanner that included gated amplifiers, Tx/Rx tuning and matching circuits, passive switching diodes, active switching PIN diodes and Transistors, AC and DC blocking, quarter wave Tx/Rx isolation, coil design, and control with a microcontroller.> Programmed software-defined radio, and designed RF transmit chains, RF receive chains, and RF coils for novel RF gradient encoding project in MR imaging.

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