mgbonardi

Experience

• Lead Product Development Engineer AgenDx Bio · Dec 2016 – Present 7 yrs 11 mos South Bend, IN, USA AgenDx Bio is a biotech start up spun out of ND, which is attempting to commercialize an early stage cancer diagnostic based on a nanomembrane technology.
  Accomplishments:
  • Designed an inexpensive high-performance disposable microfluidic device (BioChip) for delivering and concentrating BioMarkers. Including a reliable Ion Current Polarization Sample Enrichment Device.
  • Designed innovative equipment and process for manufacturing of biomarker sensor.
  • Built product requirements and specifications for end product.
  • Led efforts to design an inexpensive polarization curve device (Control Unit)
  • Created Engineering Processes and Documents
  • Multiple patent applications filed
  • Successfully recognized team shortcomings, communicated them to executive management and spearheaded fixing them.
  • Sat on Notre Dame’s Idea Center Technology Review Board
  • Participated in fundraising efforts
  • Led Cohort research project, researching AgenDx’s beachhead market
  • Promoted after 1.5 years less
• Engineering manager EasyDIal · Jul 2014 – Nov 2016 2 yrs 4 mos Irvine, CA, USA EasyDial is a start up trying to bring the first portable hemodialysis machine.
  Accomplishments:
  • Designed an inexpensive high-performance disposable flow meter (50 ml/min to 1000 ml/min).
  • Designed an economical replacement for the industry standard dialyzer connection (the Hansen Connector) saving the company an estimated 62 million dollars a year.
  • Implemented and administered the PDM system.
  • Managed small-scale manufacturing process for animal trials (injection molding, hand assembly, UV glue application and curing, ultrasonic welding, etc.…)
  • Successfully orchestrated product from concept to animal trials in 7 months.
  • Named as a member of the advisory panel to the Board of Directors.
  • Multiple patent applications submitted.
  • Managed 10+ direct reports within 4 departments.
  Mechanical Engineers, a Machine Shop Manager, Engineering Technicians, Production Engineers, Quality Engineers, and Mechanical Designers/Drafters. less