Stephan Hengstler

About Stephan Hengstler

I am an accomplished leader with 15+ years of experience in people and program management. I have extensive engineering experience in cloud, electrical, firmware, fluidics, optical, mechanical, software, and systems engineering in research and development. I practice leadership of multi-disciplinary engineering teams, product design from concept to product release with responsibilities in schedule, scope, quality, cost, manufacturability, reliability, resources, and roadmap.My portfolio of products released for commercial sale or pilot studies includes:• Amazon Home Healthcare IVD Device, 2024, IRB, IoT edge device with fluorescent imaging for daily testing• Vave Personal Ultrasound System, 2019, FDA Class II, wireless ultrasound with app and cloud integration• Vortex VTX-1 Liquid Biopsy System, 2017, RUO, microfluidic instrument for tumor cell extraction from blood• Stealth Startup Heart Monitoring Wearable, 2016, IRB, chest wearable with world’s first acoustic sensor• BD Veritor™ Plus Immunoassay Test System, 2016, FDA Class II, portable IVD device with cloud integration• BD Veritor™ Immunoassay Test System, 2012, FDA Class I, portable IVD device with embedded imagingI possess extensive experience in product development, documentation, and verification & validation for regulatory compliance, design for FDA, FCC, ISO 13485, UL and CE compliance, NPI and manufacturing transfer following cGMP.

Experience

1. Head of Hardware Development, Grand Challenge (Amazon s Moonshot Factory)

   Amazon

   Sep 2020 — Present · Milpitas, CA, US

   Assembled 16-member embedded system development organization and directed development from concept to pilot build of new AWS IoT edge device with highly sensitive fluorescent imaging for at-home customer healthcare.

Education

• University of Massachusetts Dartmouth

  Master of Science - MS, Electrical Engineering

• Stanford University

  Doctor of Philosophy - PhD, Electrical Engineering

• Karlsruhe Institute of Technology (KIT)

  Master of Science - MS, Electrical Engineering & Information Technology

Skills

• Quality System
• Engineering Management
• Biomedical Engineering
• Matlab
• Medical Devices
• Semiconductors
• R&D
• Orcad
• Field-Programmable Gate Arrays (Fpga)
• Wireless
• Systems Engineering
• Engineering
• Optics
• Image Processing
• Fda
• Verilog
• Product Development
• Embedded Systems
• Latex
• Avr
• Algorithms
• Electronics
• Sensors
• Signal Processing
• Labview
• Research and Development (R&D)
• Testing
• Electrical Engineering
• Simulations
• Firmware
• Fpga
• Embedded Software
• Digital Signal Processors
• Ic
• Manufacturing