Biomedical engineer with 11+ years of experience in medical device manufacturing, development and integration.
Experience
Lead Product Quality Engineer, GE Healthcare
Product Quality, October 2019 – Present
- Developed annual site quality metrics and worked cross-functionality with manufacturing, engineering and supplier quality teams to meet those goals.
- Designed the next generation automated test equipment platform, which integrates collaborative robotics and machine learning techniques to better detect product defects in forward-production and repair operations.
- Worked cross-functionally with the GE data science team to develop and validate a machine learning algorithm for classifying and labeling product defects using final confidence test data.
New Product Introduction, October 2018 – October 2019
- Responsible for design, development, verification and validation of electrical sub-systems of a medical imaging system for neonatal applications.
- Developed procedures for manufacturing and engineering site guidances on ESD requirements and equipment qualification.
- Established engineering procedures, templates, and standards for printed circuit boards and circuit board assembly development.
- Responsible for development and procurement of 30+ digital/RF printed circuit boards
and circuit board assemblies, including multi-layer and rigid-flex designs.
New Production Introduction, June 2018 – September 2018
- Responsible for developing and executing all service-related deliverables for the Vega NPI program release, which introduces significant software quality and performance enhancement across all MR platforms in both IB and forward production.
- Participated in multiple Customer Satisfaction Opportunities (CSO) requests for the newly released SIGNA Premier platform, included customer site visits to Germany, UCSF and Indonesia.
- Led service integration for the introduction of USB-based MR software installation, which will obsolete all DVD-based installation media by 2020. Responsible for retiring all risks related to regulatory, source and quality needs.
Scrum Master, July 2018 – September 2018
- Responsible for leading and delivering team performance-related metrics. This involves establishing team goals, scope and product domain while facilitating scrum events, requests and needs.
Senior Electrical Engineer, GE Healthcare
New Product Introduction, June 2017 – June 2018
- Led a team of engineers on the design and integration activities for a new MRI surface coil design, the 3.0T Air Anterior Array, on GE Healthcare’s latest premium MR platform, SIGNA Premier.
Platform Technology Leader, May 2017 – June 2018
- Responsible for coordinating and developing the first technology platform for re-use in all current and future surface coils.
New Product Introduction, June 2016 – April 2017
- Oversaw integration activities of sixteen legacy coils into the SIGNA Architect and Artist MRI systems. Responsible for all aspects of the coil suite verification, validation, test plan development and test execution.
- Developed software for automating analysis of essential MR image quality parameters in accordance with NEMA MS1, MS3, MS6, MS9 and IEC 62464-1 standards.
New Product Introduction, 2014 – June 2016
- Oversaw development and product integration of the 1.5T Posterior Array coil and legacy coils on the SIGNA Voyager MRI system.
- Led design changes to reduce the ICV of the SIGNA Voyager MR coil suite by 25% (when compared to the previous generation MR coil suite).
- Established standards and guidelines for hierarchical PCB design and technical block diagrams.
New Product Introduction, 2013 – 2014
- Developed the 3.0T TDI Posterior Array, the first GE coil to use Micro-Electrical Mechanical System (MEMS) technology.
- Reduced material and labor of the 3.0T posterior array coil by over 60%, when compared to the previous generation of coil technology.
- Developed a common test guideline for characterizing essential MR image quality parameters in accordance with NEMA MS1, MS3, MS6, MS9 and IEC 62464-1 standards.
Product Redesign, 2012 – 2013
- Redesigned the 3.0T GEM posterior array to be the most reliable coil manufactured by GE Healthcare to date.
- Improved the B10 of the 3.0T GEM posterior array from 90 days to 1000+ days.
- Simplified 3.0T GEM posterior array design by reducing the number of unique buy sub-assemblies by 40%.
Automated Test Equipment Development, 2011 – 2012
- Developed and implemented the first vibrational automated test equipment to allow up to 32 RF channels of simultaneous acquisition while testing MR coils in forward-production.
- Developed software for automated test equipment that measures critical parameters as part of forward-production confidence testing.
Installed Base, 2011 – 2012
- Led engineering design changes to increase the reliability of GE Healthcare Coil’s leading root-causes for field returns.
Education
Case Western Reserve University
Bachelors of Science, Biomedical Engineering, 2011
Skills and Training
- Advanced Design System (ADS)
- Agilent VEE Programming Training
- Agile Scrum Master Training
- Altium Designer 22.0
- Building Essential Leadership Skills (BELS) Training
- C and Python programming Language
- Cadence 17.2
- Concord Pro
- GE Fundamentals of Leadership (FOL) Training
- GE Leadership Development Course (LDC) Training
- LabVIEW 2016
- MasterControl Quality Management Software
- MATLAB
- Rally Tools
- Remcom XFdtd 7.7
- Six Sigma (DFSS & DFMEA) Training
- Tableau Desktop
Patents and Publications
Rashid, S., Pho, G., Czigler, M., Werz, M. A. and Durand, D. M. (2011), Low frequency stimulation of ventral hippocampal commissures reduces seizures in a rat model of chronic temporal lobe epilepsy. Epilepsia. doi: 10.1111/j.1528-1167.2011.03348.
Broekhoven, L. H.; Brooker, B.; Czigler, M.; Donald, M. W, Maximum-likelihood estimation of the accuracy of auditory discrimination in the absence of an overt response to every stimulus, Behavior Research Methods & Instrumentation, Vol 15(5), 483-486.
Dalveren, Taylan, Dan K. Spence, Limin Feng, Michael Czigler, and Gabriel Searles. Apparatus and Method for Decoupling an Mri Receive Coil. Patent US20160341804 A1. 24 Nov. 2016. Print.