Paul Hoseit

About Paul Hoseit

Extensive Product Development, System Engineering, Project & Functional Management Experience Large complex multidisciplinary cross functional developments: Medical Device (Cardiovascular & Cell Therapy) and other industries (Industrial Machine Monitors, Petroleum Processing, Weather, Security) Fully versed in Medical Device Design Controls and Quality Systems.* Many years of Engineering Functional/Executive Management Experience - Directed Electronic, Software, Mechanical, Optical, Signal & Image Processing, System Engineering, Test.(R&D departments up to 80 people) Medical Device Product Development Infrastructure & Process Developer. Quality System Implementation. Contract Engineering and Manufacturing Management.* Medical Device Product Development Consultation: Program Management, System Design, Requirements, Specifications, Safety/EMC, V&V * Individual Contributor Designs comprising: System Design, Embedded Software Developer (embedded firmware) Analog and Digital Electronics Design - high precision, Medical & Industrial environments.* Large portfolio of released (US, EU, Japan, ROW) embedded instrument based products in Medical Device and several other industries. Patents Patents (5,473,311 5,475,365 5,578,988 5,581,236, 6,585,660, 7,134,994, 8,556,820, 8,562,537, 8,636,659, 9,392,979, 9,486,143, 10,058,284, 10,463,263, 10,646,200, 10,869,603)) Specialties: Medical Device, System Engineering/Product Development Instrumentation, Imaging, Embedded Software and Electronic Design, Signal Processing, Intravascular Ultrasound, Intravascular pressure and flow measurement, Optical Coherence Tomography, Near Infrared Imaging, Blood and Stem Cell harvesting and processing devices.

Experience

1. Principal Consultant

   Qserve Group

   Aug 2021 — Present · US

   Qserve’s mission is to help improve patient health and safety by supporting the advancement of biomedical technology. We assist medical device and in-vitro diagnostics manufacturers worldwide with market access, medical device approvals, clinical trials and achieving and maintaining regulatory compliance. We strive to do this with a practical approach balancing business needs and regulatory compliance. My emphasis is on design controls, system/software engineering requirements/specifications, risk management, usability engineering, electrical safety/emc and V&V.

Education

• California State University-Sacramento

  MS, Biomedical Engineeering

  1982 — 1985

• California State University-Sacramento

  BS, Electronic Engineering

  1981 — 1984

• Santa Clara University

  BS, Biology

  1976 — 1980