MD System Engineering (HW/SW), Design, Safety
Paul Hoseit has been designing and developing electronic/embedded software instrumentation for over 35 years, 22 years in Medical Devices. While an individual contributor, he designed, specified, and developed analog, digital and embedded software (firmware) instruments for industrial, meteorological, consumer and predominately medical markets. As a System Engineer, he has architected and program managed several successful physiological, cell therapy and imaging platforms.
Paul also has extensive Technical/Product Expertise including Critical to Quality (CTQ), Electronics, Signal Processing, Embedded Software, System Architect Level, System of Systems, Error/Fault Management, Usability, Service, HIPPA, Installation, Diagnostics, manufacturing tests and IFU.
He holds a B.S. in Biology, B.S. in Electrical/Electronic Engineering and a M.S. in Biomedical Engineering.
Throughout his Medical Device career, Paul has managed developments for the global market with an emphasis on USA, EU and Japan. During this period, he functionally managed engineering departments (i.e. over 80 Engineers at Volcano Corp). Paul has years of experience in design controls, user needs, requirements, specifications, risk analysis and verifications of complex medical instruments. Paul has been working as a “hands on” Vice President of Engineering for over the last 10 years for: Volcano Corp. (Intravascular Ultrasound & Invasive Pressure – Cardiovascular), Evena Medical (Infrared Vein Imaging), SynGen (Cell Separation and Preservation), Thermogenesis (Cell Separation and Preservation), Phyzhon Health Inc. (Cardiovascular).
The key expertise area's of Paul:
- Advising on Design Controls, FDA 21 CFR Part 820.30, ISO 13485 for electromechanical medical device instrumentation, creating of content for User Needs, Use Flow, Product Requirements, Low Level Specifications, Software Requirements, Architecture Descriptions, Design Descriptions, Hardware & Software Verification Plans, Protocols, Reports, System Verification Plans/Reports, System User Validation, Design Reviews & Traceability.
- Advising on Risk Analysis EN ISO 14971, creating content for Hazard Analysis, Use FMEA, Design FMEA. Advise on mitigations.
- Advising on Software including IEC 62304 Software Lifecycle, FDA Level of Concern, Software Development Plan.
- Recommending Electrical Safety and EMC & advising on system design to satisfy IEC/EN 60601-1 General Safety of Medical Devices, IEC/EN 60601-1-2 Electromagnetic Compatibility of Medical Devices, experience with some particular safety standards like IEC/EN 60601-2-34 (invasive blood pressure), IEC/EN 60601-2-37(ultrasound), IEC/EN60825 (laser products).
- Consulting on Program Management for Design and Development Planning System & Software, Schedules, Cross Functional Management Meetings/Minutes, Phase Reviews, Design Transfer, Design History Files, Engineering Organization/Management.
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