Luke Zanetti

Project Engineer II at A-BIO
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Location
Baltimore, Maryland, United States, US

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Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Project Engineer II
      • Dec 2022 - Present
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior R&D Engineer
      • Mar 2022 - Present

      Engineer designing and developing implantable cardiac medical devices including mitral valve repair systems, hemostasis introducers, and left ventricular remodeling devices. Primary responsibilities are design verification testing, supplier development, and design for manufacturability. • Filed 7 Patents with 16 more in progress. • Led the design and development of a hemostasis Introducer which included designing CAD models, engineering drawings, and inspection… Show more Engineer designing and developing implantable cardiac medical devices including mitral valve repair systems, hemostasis introducers, and left ventricular remodeling devices. Primary responsibilities are design verification testing, supplier development, and design for manufacturability. • Filed 7 Patents with 16 more in progress. • Led the design and development of a hemostasis Introducer which included designing CAD models, engineering drawings, and inspection plans. • Responsible for design verification testing.

    • R&D Engineer II
      • Mar 2019 - Mar 2022

      Engineer designing and developing implantable cardiac medical devices to treat structural heart disease. Primary responsibilities were prototyping and testing design solutions and developing design control documents including product specifications, test method development, engineering drawings, dFMEA, process improvements, and part qualification plans for the commercialized device. • Created over 30 test fixture CAD models, engineering drawings, and installation qualification (IQ) •… Show more Engineer designing and developing implantable cardiac medical devices to treat structural heart disease. Primary responsibilities were prototyping and testing design solutions and developing design control documents including product specifications, test method development, engineering drawings, dFMEA, process improvements, and part qualification plans for the commercialized device. • Created over 30 test fixture CAD models, engineering drawings, and installation qualification (IQ) • Developed and validated test methods for design verification testing. • Led technical development of the next generation hemostasis Introducer. • Utilized rapid prototyping skills and 3D printing to design various samples for surgeon testing. • Conducted voice-of-customer testing with surgeons throughout the US and EU to generate user needs and product specifications.

    • R&D Engineer
      • Dec 2017 - Mar 2019

      Engineer working on the design transfer and manufacturing scale-up for commercial launch of an innovative mitral valve repair system. Primary responsibilities were equipment design for manufacturing, product failure mode analysis, new process development and implementation, development and implementation of good manufacturing practices, design verification, and development of product specifications. • Prototyped and optimized the design of manufacturing fixtures. • Authored… Show more Engineer working on the design transfer and manufacturing scale-up for commercial launch of an innovative mitral valve repair system. Primary responsibilities were equipment design for manufacturing, product failure mode analysis, new process development and implementation, development and implementation of good manufacturing practices, design verification, and development of product specifications. • Prototyped and optimized the design of manufacturing fixtures. • Authored manufacturing procedures and trained cleanroom operators. • Provided technical product expertise in animal studies. • Oversaw the on-time completion of a device’s first commercial build for Edwards Lifesciences..

    • R&D Engineer
      • Jun 2016 - Dec 2017

      Engineer working on the development of innovative mitral valve repair system. Primary responsibilities have been in Equipment Design for Manufacturing, New Product Concept Development, Product Failure Mode Analysis, and Anatomical Surgical Training Model Development. Accomplishments • Patented a novel Method and apparatus for cardiac procedures • Designed the next generation EPTFE Preformed Knot Winder • Prototyped and Developed new device concepts to investigate methods of… Show more Engineer working on the development of innovative mitral valve repair system. Primary responsibilities have been in Equipment Design for Manufacturing, New Product Concept Development, Product Failure Mode Analysis, and Anatomical Surgical Training Model Development. Accomplishments • Patented a novel Method and apparatus for cardiac procedures • Designed the next generation EPTFE Preformed Knot Winder • Prototyped and Developed new device concepts to investigate methods of improving device navigation under echocardiography • Observed surgeries and utilized product expertise to conceptualize product improvements • Developed Anatomical Mitral Valve Repair trainer

    • R&D Engineering Intern
      • Feb 2015 - Jun 2016

      Engineering intern conducting research to characterize valved introducer leakage in surgical scenarios and designed new product solutions. Accomplishments • Received Intern of the Year Award from The University of Maryland • Established road map for new introducer valve through product research

    • United States
    • Research Services
    • 700 & Above Employee
    • Research Assistant Intern
      • May 2014 - Aug 2014

      Research intern developing screening methodologies for E. Coli species to support bioinformatics research. • Developed and utilized methods to screen samples with PCR, spectrophotometry, gel electrophoresis, selective growth media, and other chemical assays. • Credited as an author for supporting research on “Responses to Human gut E. Coli to Pathogen and Antibiotic Disturbances.” Research intern developing screening methodologies for E. Coli species to support bioinformatics research. • Developed and utilized methods to screen samples with PCR, spectrophotometry, gel electrophoresis, selective growth media, and other chemical assays. • Credited as an author for supporting research on “Responses to Human gut E. Coli to Pathogen and Antibiotic Disturbances.”

    • United States
    • Recreational Facilities
    • 1 - 100 Employee
    • Headguard
      • May 2012 - Aug 2014

      During the Summers Managed a staff of approximately 30 other guards with the assistance of two other Headguards Certified in CPR and first aid; treated minor injuries and as first responder to major injuries stabilized and activated EMS as needed. Handled many complaints and concerns from members and made sure that they received professional and great service while solving all possible concerns During the Summers Managed a staff of approximately 30 other guards with the assistance of two other Headguards Certified in CPR and first aid; treated minor injuries and as first responder to major injuries stabilized and activated EMS as needed. Handled many complaints and concerns from members and made sure that they received professional and great service while solving all possible concerns

Education

  • University of Maryland College Park
    Bachelor of Science (B.S.), Biomedical/Medical Engineering
    2012 - 2016
  • University of Maryland
    Master of Engineering - MEng, Engineering, Focus in Reliability Engineering
    2022 -

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