Hello!
I’m Dominik Schuster, a Software and Hardware Engineer specialized in Medical Devices.
About Me & My Work
During the last 11 years I worked as engineer and project manager in the development of active medical class III devices.
Next to the software and hardware development of these devices, I accompanied the whole development process beginning with the evaluation of market requirements and ending with a complete set of design output files for a validated, standards compliant device, ready for submission to the notified body / FDA.
Since 4 years I work as freelancer and support my customers in all phases of a complete design process as shown in the following process diagram:
1
Idea Phase
Evaluation of market requirements; Definition of the product
2
Concept phase
Definition of product requirements; Creation of a evaluation models; Support of feasibility studies
3
Prototype Phase
Development of product specifications; Development of prototypes; Verification and validation of prototypes
4
Transition to Production
Development of the Pilot series; Finding production partners; Support of the production and validation process
5
Certification
Preparation of certification documents; Support during the complete certification
My Services
Development
Firmware Development
Application Development
Electronic Design
Testing
Software & Hardware Module Tests
Integration Tests
Acceptance Tests
Regulatory
Design Documentation
Risk Management
Failure Mode and Effect Analysis
Evaluation of Standards
Project Management
Project Planning
Project Tracking
Coordination of Project Members
Skills
Implementation of firmware projects for ARM Cortex or other microcontroller families in C according to IEC 62304
Code implementation to drive peripheral modules (GPIO, Timer, ADC, RTC, Crypto, ...) and bus systems (UART, I²C, SPI, USB, ...)
Use of realtime operating systems such as FreeRTOS, TI-RTOS, ...
Implementation of hardware drivers for all kind of commonly used devices (sensors, displays, memories, actuators, ...)
Development of bootloader, data communication, data encryption and user interface modules
Implementation of communication interfaces such as Bluetooth, Sub 1 GHz RF, MICS, UMTS/LTE, ...
Development of .NET desktop applications based on the Windows Presentation Framework (WPF)
Development of .NET desktop applications based on Windows Forms
Implementation of applications to monitor, control or perform firmware updates on embedded devices
Implementation of applications used for data analysis
Development of applications used to perform automated system integration tests
Implementation of automated software module tests
Development of digital and analog circuits consisting of active and passive components such as voltage regulators, microcontrollers, sensors, displays, memory or RF ICs, antennas, ...
Layout of PCBs according to IEC 60601-1
Development of test adapters to perform hardware module tests
Obsolescence management (replacement of components with suitable alternatives)
Work Experience
Freelancer / 2019 – today
Schuster TechConsult
Weßling, Germany
Development of
Active Medical Devices / Implants
Freelancer / 2014 – 2019
Schuster TechConsult
Weßling, Germany
Maintenance of
Active Medical Devices / Implants
Employee / 2015 – 2019
Dualis MedTech GmbH
Seefeld, Germany
Project Manager & Leading Software Engineer
Active Medical Devices / Implants
Employee / 2013 – 2015
Dualis MedTech GmbH
Seefeld, Germany
Leading Software Engineer
Active Medical Devices / Implants
Employee / 2012 – 2012
Dualis MedTech GmbH
Seefeld, Germany
Software Engineer
Active Medical Devices / Implants
Clients
