Supporting the engineering team with the elaboration of a safety-related design for an insulin patch pump.

Supporting the engineering team with the elaboration of various design artifacts related to an FDA PMA submission, and the elaboration of a development environment for class III active implants.

I offer consulting and coaching services in the field of product development of safety-critical systems. My strength is my broad experience from different areas, which enables me to apply best practices across domain boundaries.Here a selection of my consulting and coaching services:- Risk-based HW/SW architecture development- Attaining single-fault safety acc. to IEC 60601-1 by design- Avoiding SW/HW related hazards acc. to IEC/TR 80002-1- Applying HW/SW risk management acc. to ISO 14971- Tool environments for compliant Medical Device development- Process elaboration for Medical Devices development- Independent reviews of HW/SW architectures & designs- Coaching of HW/SW development teams- Functional Safety trainingSelection of standards:- IEC 61508, EN 50126/28/29/59, IEC 61800-5-2- IEC 60601-1, IEC 62304/82304, IEC/TR 80002-1, IEC 62366-1- IEC 62443-4, IEC 81001-5-1 (Medical Device Cyber Security)- Various FDA guidelines & MDR related documentsLet me know if I can help you!

As a member of 'Ypsomed Delivery Systems', collecting stakeholder inputs and elaborating Use Cases, phrasing of requirements across multiple levels of abstraction (using IBM DOORS Next Generation), supporting risk analysis and standards interpretation, interfacing between various disciplines (HW, SW, Mechanics, Risk, Product Management).Furthermore: Supporting various projects with Functional Safety expertise, incl. appropriate training.

Responsible for a team of about 6 embedded SW engineers (company internal and external) for writing safety-critical Medical Device SW according to IEC 62304.

As a member of the Embedded Software team, focus on the improvement of the Embedded SW development environment (build tool-chain) and the associated processes, procedures and tools.Furthermore, supporting the project teams with questions about the SW lifecycle according to IEC 62304, and Functional Safety aspects (single-fault-safety according to IEC 60601-1).

Areas of work: Sensors & Medical Electronics, Medical Embedded Software, Home & Office ApplicationsAs a consultant, contributions to many research and development projects in multidisciplinary and multicultural teams in various roles: Embedded Systems architect incl. safety-related devices, SW architect, SW programmer (C/C++, LabVIEW/TestStand and VHDL), SW sub-project leader, independent reviewer for HW & embedded SW, requirements engineer, DevOps engineer, coach of younger colleagues.Furthermore, lead in the introduction of Test Driven Development (TDD), major contributions to the implementation of the tool-chain automation (Continuous Integration) for various families of micro-controllers, major contributions to the improvement of the SW lifecycle according to IEC 62304 (SW Quality Assurance), contributions to the design and implementation of lab and verification test equipment (e.g. goniometer with LabVIEW, automated Use Case Tester with LabVIEW/TestStand, lab data analyzers with LabVIEW).

Working in a team of around 8 Embedded SW/HW developers on the iterative elaboration (RUP) and implementation (C99, C++98/03) of a platform for a sophisticated battery control device for telecom power applications (PowerPC with real-time operating system MQX, many communication protocols, embedded webserver, etc.) using many concepts of Extreme Programming (XP) – e.g. Test Driven Development (TDD) with Continuous Integration (CI) and Pair Programming – in order to write high-quality and reliable software.Furthermore, HW and SW design for the measurement module with analog and digital I/Os according to telecom standards (+/- 75V) as well as the SW development of the production test equipment (various needle adapters) with LabVIEW and TestStand for the mass production in Asia, incl. 2nd level support.

Redesign of various electronic circuits (analogue & digital) of a new franking machine based on HP Inkjet technology, constructed around the Intel 386ex platform and a large FPGA.

Design and verification of analogue circuits for low-cost, high-volume (> 500’000 pieces/year) 24VDC and 230VAC damper actuators for heating, ventilation and air-conditioning (HVAC) incl. motor control techniques for various types of DC motors.

Class D power amplifier with 2.5kW running in the frequency range DC to 2MHz for a new series of medium wave (MW) solid-date radio transmitters (5..100kW) using the latest MOSFET technology available at that time, a sophisticated gate driver design and an impedance-controlled circuit board layout.

Further development of the work I started as a trainee, but also participation in other activities within the ‘Applied Superconductivity Center’, like running a cryogenic experiment and writing a scientific paper.

My workplace was the 'High Current Lab' of the 'Applied Superconductivity Center'.Design and implemented of a fail-safe protection system (quench detector) for two mutually coupled superconducting magnets (asset of $250’000) for continuous operation close to a high magnetic field of up to 5T.