Christoph Lüdi
Head Systems Engineering, Systems Architect
Oberbipp
Summary
Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives . Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.
Overview
28
28
years of professional experience
8
8
years of post-secondary education
Work History
Head of Automated Factory
Bystronic
Niederönz
9 2023 - 7 2024
- Leading Requirements and Testing Departments with total 10 engineers
- Presented 2-years plan to introduce systems engineering processes, methods and tools to align all organizations covering mechanical, electronics, software and optical engineering in Switzerland, Germany, Spain, Italy and China
- Created SysML model of automated factory
Associate Director Engineering
Novartis
Basel
03.2021 - 08.2023
- Led team of 4 lead system engineers to develop reference architecture for connected health ecosystems: combining model-based systems engineering (MBSE) architectures, Domain-Driven Design (DDD) domain models, and feature models
- Led cross-organizational systems engineering (SE) focus group of 7 systems engineers: authoring systems engineering standard operating procedure (SOP), perform workshops on SE education and implementing MBSE business processes, and introduced MBSE tool Cameo Systems Modeler
- Supported three projects for innovative solutions with different stakeholders in different domains of connected health business processes.
Senior Device Manager
Novartis
Basel
07.2019 - 02.2021
- Shaped and led new cross-organizational SE focus group
- Authored and introduced new SE working procedure based on RFLP (requirements, functional, logical and physical architectures)
- Developed, communicated and documented full SysML system architecture of connected auto-injector in real project to introduce MBSE directly on the job
- Developed and communicated examples of asset-based product line platforms, based on feature models
- Initiated evaluation of alternative SysML tools.
Electronical Hardware and Software Development Expert
Novartis (Contractor Position)
Basel
01.2019 - 06.2019
- Drove early systems engineering initiative, by integrating functional and logical architectures with requirements using Sparx Enterprise Architect
- Led technical development activities for electronic medical device components and complex topics
- Created technical documentation of liquid drug injection combination products.
Head Systems Engineering
Sensile Medical
Olten
07.2014 - 12.2018
- Successfully set up and led new systems engineering department with 3 systems engineers and new SE methodology covering process, methods, and IT tools
- Integrated systems engineering process into development process of interdisciplinary medical devices/combination products
- Provided major contributions to requirements, architecture, FMEA and risk analysis for app-controlled insulin patch pump.
Head Software and Electronics Engineering
Sensile Medical
Hägendorf
04.2012 - 06.2014
- Led the team of 5 software/electronics engineers and coordinated their activities in various projects
- Provided specifications of requirements, architecture and design with full traceability, as well as essential input to FMEA and software development for an Apomorphin infusion pump with 2 controllers, screen based UI, SW safety class C, and a Furosemide patch pump
- Evaluated, configured and initially administered requirements management tool 3SL Cradle.
Manager Software Development
Sensile Medical
Hägendorf
06.2007 - 03.2012
- Successfully set up and led initial medical software development department with 3 software engineers and a development process per IEC 62304 in new startup company
- Defined system- and software requirements, architecture and design of new pump device
- Defined software requirements, architecture and design, selected controller and set up RTOS and development environment, developed source code in C for a device demonstrating pump technology
- Led project for glucose monitor: Recruited employees and development partners, selected hardware and OS, planned, specified system and co-developed in C#, planned and co-executed tests per IEEE 829
- Trained the intensive care unit staff of the University Hospital Zürich for the clinical trial
- Initiated, evaluated, configured and initially administered the UML/SysML modeling tool MagicDraw.
Sabbatical
N/A
Worblaufen
02.2007 - 05.2007
- Considered professional change: analyzing personal strengths and preferences
- Pursued private software projects.
Software Profession Manager
Bernafon
Bern
02.2002 - 01.2007
- Led team of 12 C++ software developers
- Coordinated software activities with Danish sister company Oticon (30 developers)
- Reorganized SW development process with great success from architecture-based to agile approach with vertical feature teams, based on role-based team innovation process and requirements engineering
- Evaluated requirements management tool RTM Workshop and planned pilot project
- Evaluated UML modeling tool MagicDraw to replace Together C++.
Software Project Leader
Bernafon
Bern
02.2000 - 01.2002
- Led software project for new hearing instrument family
- Led development of new hearing instrument platform in C++ and supervised its use in projects
- Initiated, evaluated and administrated UML modeling tool Together C++
- Initiated, evaluated, configured and initially administered software configuration management tool Rational/IBM ClearCase with ClearQuest.
Software Developer (C++)
Bernafon
Bern
05.1998 - 01.2000
- Initiated development of object-oriented domain framework in C++ using UML to serve as platform for all instrument models
- Developed Japanese version of fitting software
- Initiated, evaluated, introduced and administrated the source-code browsing tool SNiFF+ for C++.
OO Developer (Smalltalk, C++)
FIDES Informatik
Worblaufen
09.1996 - 04.1998
- Developed reusable components for Fides framework 'RAP' in IBM VisualAge Smalltalk
- Acted as technical expert for IBM VisualAge Smalltalk at Schweizerische Mobiliar Versicherungsgesellschaft in Bern
- Developed server functions on UNIX/C++, ORACLE database at UBS Zürich.
- Worked closely with clients to gather requirements and translate them into technical specifications for implementation.
Trainee
Yaskawa Electric Corp.
Tsukuba
07.1995 - 03.1996
- Developed programming system for human-like robot hand: Japanese team, UNIX C, HP handheld device
- Before: Three month Japanese intensive course in Kanazawa; Japanese Proficiency Test Level 3 (intermediate).
Education
Certificate - Architecture and Systems Engineering
Massachusetts Institute of Technology (MIT)
Online 09.2016 - 03.2017
MBA - Management, Technology and Economics/BWI
ETH Zürich
Zürich, Switzerland 10.2004 - 11.2006
Diploma (Master) ETH - Microtechnology
EPFL Lausanne
Lausanne, Switzerland 10.1989 - 03.1995
Skills
Friendly, Positive Attitude
Accomplishments
· Standardized development processes with new Systems Engineering Standard Operating Procedure (Novartis)
· Introduced model-based documentation (Novartis)
· Achieved regulatory compliant product specifications with new Software and Systems Engineering departments and -processes (Sensile Medical)
Languages
German
English
French
Japanese
Software
MS Office (Word, Excel, Outlook, PowerPoint)
3SL Cradle
NoMagic MagicDraw/Cameo
Dassault Magic Cyber Systems Engineer
Sparx Enterprise Architect
Polarion
Standards
- ISO 13485
- ISO 14971
- IEC 62304
- IEC 60601
- ISO 11608
Timeline
Associate Director Engineering
Novartis
03.2021 - 08.2023
Senior Device Manager
Novartis
07.2019 - 02.2021
Electronical Hardware and Software Development Expert
Novartis (Contractor Position)
01.2019 - 06.2019
Certificate - Architecture and Systems Engineering
Massachusetts Institute of Technology (MIT)
09.2016 - 03.2017
Head Systems Engineering
Sensile Medical
07.2014 - 12.2018
Head Software and Electronics Engineering
Sensile Medical
04.2012 - 06.2014
Manager Software Development
Sensile Medical
06.2007 - 03.2012
Sabbatical
N/A
02.2007 - 05.2007
MBA - Management, Technology and Economics/BWI
ETH Zürich
10.2004 - 11.2006
Software Profession Manager
Bernafon
02.2002 - 01.2007
Software Project Leader
Bernafon
02.2000 - 01.2002
Software Developer (C++)
Bernafon
05.1998 - 01.2000
OO Developer (Smalltalk, C++)
FIDES Informatik
09.1996 - 04.1998
Trainee
Yaskawa Electric Corp.
07.1995 - 03.1996
Diploma (Master) ETH - Microtechnology
EPFL Lausanne
10.1989 - 03.1995
Head of Automated Factory
Bystronic
9 2023 - 7 2024