Professional Experience

• More than 10 projects in the fields of MEDICAL TECHNOLOGIES, MEDICAL DEVICES, BIOTECH, PHARMA and combination products. More than 20 years of professional experience in international teams, mainly in Germany and Switzerland, but also in Ireland, the USA, the UK, Spain, France, Italy, Romania, Austria and Hungary, as well as with various teams in Sweden, Mexico, Egypt, Israel, Australia and Asia (China, South Korea, India, Philippines and Japan).
• Other end customers and employers in other business areas: CERN (European Organisation for Nuclear Research)
• Additional Know-How in Pharma, BioTech, Biomedicine & Biology ? Cancer, Aging, Longevity, Omics ?Genomics, Epigenomics, Proteomics, Transcriptomics, Metabolomics-, Lab-grown organs, etc (Research, Services, Products, Networking, etc)
• Several Audits: supplier Audits, internal Audits, mock-up Audits (ISO 13485, MDSAP, GCP, GMP, GAMP 5, GLP, GxP, FDA 21 CFRs, FDA 21 CFR 58, ISO 9001, ISO 14971, EN 62304, EN 62366, EN 60601, EU/ MDD/ MDR/ IVDD/ IVDR, USA/FDA, Canada/HC, Australia/TGA, Brasil/ANVISA, Japan/MHLW, etc)

• Applied and theoretical knowledge of MEDICAL TECHNOLOGIES/ PHARMA/ BioTech Specifications and Laws/Regulations: Design, Quality, Regulatory Affairs, GxP, GMP, GCP, GLP, GAMP 5, CSV (Computer System Validation), FDA 21 CFRs, FDA 21 CFR 58, Digitalization, Toolchain/ALM/PLM coaching, process documentation, 93/42/EEC, 2007/47/EC, 2016/MDR (Medical Device Regulation), 510k submission, EN ISO 13485(Quality Management), EN ISO 14971 (Risk Management), EN 62304 (Software Lifecycle), Usability (EN 62366 & EN 60601-1-6), LIMS, FDA 21 CFR part 820. Other: DICOM, LOINC, HL7, FDA 21 CFR 803, FDA 21 CFR 806, MES, ISO/IEC 15026-2, ISO 9001, ISO 9003, GxP/ GEP/ GMP/ GAMP/ GCP/ GCP/ GCLP/ GDP, EN 60601, IEC 12207, IEC 61508, ISO 61010, GAMP-CSV.
• REQUIREMENTS ENGINEERING: Project experience in Requirements elicitation, analysis (project, negotiation, specification and modeling (e.g. SysML/UML) and management. Also Template creation, DXL scripting, etc. Variant Management for Requirements Engineering.
• R&D, MODELING, SIMULATION, SYS&SW&HW DESIGN/ARCHITECTURE and Programming Techniques: Machine Learning/ Algorithmics/ Data Science/ Artificial Intelligence/ Big Data/ Neural Networks/ Deep Learning/ HMI development (Human Machine Interface) and Usability/ UI-UX/ User Interface/ User Experience/ IxDF/ Virtual Reality (VR) ? Augmented Reality (AR), SCRUM, Agile, V-Model, SysML, UML Modeling, OOA, OOD, OOP (Object Oriented Architecture, Design & Programming), Databases, AUTOSAR 4, Model-driven Development, Automatic Code Generation, Architecture & Design Patterns, Reverse Engineering.
• QUALITY MANAGEMENT/ PROCESS: ISO 13485, Audits, Quality Management, Risk Management, GxP, GMP, GCP, GLP, GAMP 5, CSV, FMEA issuing and moderation as well as experience as Quality System and Software Engineer in the MedTech branch (DHF, DMR & DHR: development and remediation activities, and CAPA). Supplier Quality, Supplier Management, Reporting. Experience also as project manager for process improvement and assessment preparation, in an international multi-site development scenario. V-Model, SCRUM and Extreme Programming/Agile.
• RISK MANAGEMENT & FUNCTIONAL SAFETY & Critical System Design & Development in the Medical Technologies, Pharma and Automotive Branches: Experience as Risk/ Functional Safety Manager, Functional Safety Engineer, Functional Safety Project Leader and Functional Safety SW implementation Team Leader. DIA (Development Interface Agreement), Risk and Hazard Analysis, Functional Safety Plan, Technical Safety Concept Specification (Reqs & Arch), FuSa HSI, FMEA, FTA, FMEDA, FuSa V&V (Testing), etc. ISO 14971, ISO 26262 and IEC 61508.
• PROJECT MANAGEMENT/ TEAM LEADERSHIP: Project experience in Planning and Tracking, Scrum, Action Point List generation and tracking, meeting and workshop organization and chairing, preparation of slides for presentations, presentation skills, soft skills, cost calculation, budgeting, external resource acquisition, interviewing, commissioning.
• Experience in BUSINESS MANAGEMENT, Marketing, International Relations, Client & Partner Acquisition & Care, Presentation & People Skills, Purchasing, Tax Systems and Contract Negotiation.
• QUALITY ASSURANCE & TESTING: CSV (Computer System Validation), Testing Plan, Testing Management, Unit Testing, HIL, SIL, Unit Testing, Endurance/Long-term Testing, Automated & Managed Testing. Experience in Regulated (V-Model, Water-Fall), Agile and mix development environments. Understanding of the importance of client-facing roles, excellent customer service and communication skills. Good team member understanding of wrap-around development and testing processes. Solid understanding of test case design implementation and reporting, Regression testing and automation, Solid analytical approach, Good understanding of the place of creativity in the testing and mitigation process. Experience in Code Reviews and Static Rule Checking. Knowledgeable about different testing, development and defect tracking tools.
• HARDWARE DEVELOPMENT & TESTING: PCB Schematics and layout (plus component footprints), EMC/EMV, FPGA development, laboratory testing experience.
• MICROPROCESSORS: different Texas Instruments SoCs & DSPs, NVidia SOCs and GPUs, ALTERA SOCs, XILINX SOCs, Mobileye EyeQ, Infineon TriCore, TI Jacinto, TI OMAP 5, ARM7, ARM9, ARM11, ARM Cortex A15, ARM Cortex M4, Infineon Aurix, Freescale ColdFire, Renesas SH-4, Xilinx Microblaze.
• EMBEDDED OPERATING SYSTEMS: RTOS and non-RTOS. OSEK, QNX, Embedded Linux, Express Logic ThreadX, MS WinCE, Texas Instruments DSP BIOS, Freescale MQX? Also experience with very low resources systems with no embedded operating system.
• Areas of SPECIALIZATION in the SYSTEMS DEVELOPMENT: MedTech Devices, Pharma and Biotech (e.g. Pharma production facilities, minimal invasive chirurgical electro-mechanical devices -robots- for brain/spine surgery, MRT device, X-ray device, electronic blood infusion pumps, in-vitro diagnostics, video-cameras for medical appliances, pharma and medical research electronic devices).

• RISK MANAGEMENT, FUNCTIONAL SAFETY and QUALITY MANAGEMENT: GessNet TurboAC, KPIT Medini Analyze, APIS IQ-SW, Plato FMEA, Method Park STAGES, LINT, Coverity, QAC, Polyspace, Klocwork, etc
• REQUERIMENTS ENGINEERING: IBM DOORS (+ DXL), Polarion, MKS/PTC, HP Quality Center, Borland Caliber, Orcanos QPack, Banana Scrum, HOOD DESIRe, Pure::variants and Big Lever Gears for Variant Management in Requirements Engineering.
• Process Definition, Modeling, Simulation, Product & Application Lifecycle Mgmt (PLM/ ALM), Integration, VERSION Control, CHANGE, CONFIGURATION, VARIANT Mgmt Tools, ReqEng, Testing, SW&HW ARCHITECTURE & DESIGN: BPMN (Business Process Model & Notation) & ADONIS BPM & ADOIT Suite, BPM/PBMN & ADONIS SysML & UML (IBM Rational Rhapsody, SparxSystems Enterprise Architect, MID Innovator, IBM Rational Rose, Microsoft VISIO and StarUML), Polarion, MKS / PTC Integrity, Perforce P4V, Telelogic-IBM ALM toolchain, Atlassian tools (JIRA, etc), Subversion and CVS, Serena Team Track & PVCS, pure systems pure::variants, BigLever Gears, GIT, MAVEN, Jenkins, IBM DOORS (+ DXL), HP Quality Center, Borland Caliber, Orcanos QPack
• TEAM LEADING, PROJECT MANAGEMENT & OFFICE APPS: MS Office (Word, PowerPoint, Excel, Access, Visio), MS Project, Microsoft Team Foundation Server (MS TFS), Actano RPLAN e3, ERPs and Warehouse Mgmt (SAP, GUS, etc), Mindjet MindManager
• PHARMA/ Biotech/ Medical/ LAB tools : Minitab, STARLIMS & LabWare LIMS & ELN, MES (for MedTech/Pharma/BioLabs)
• SOFTWARE Development Environments, Programming Languages & Integration TOOLS: C/C++, Python & R, PyTorch, TensorFlow, Scikit-Learn, C#, VBScript, Java, LabView, MATLAB, Simulink, Delphi, SQL, PHP, Anaconda, Zeppelin & Jupyter Notebooks, Gitlab CI/CD, DVC (Data Version Control), Kubernetes, Docker, HADOOP, Amazon AWS, Value Cloud, Celery, ONNX AI, DJANGO, React ? JavaScript, REST APIs, GitOps, Argo CD, JIRA, Confluence, MS Team Foundation Server, Google Cloud, embedded C/C++, GitHub, MAVEN, Jenkins, Eclipse, Xilinx SDK, MS Visual Studio, Tableau, Freescale CodeWarrior, TI Code Composer Studio, IAR Embedded Workbench, Looker, ARM RealView Dev Suite, Qt, Tcl/Tk, D?Oxygen, Open GL (ES) API, NVidia GPUs, Adobe Flash Lite, etc.
• QA/Testing: HP/MicroFocus Quality Center, GIT, Polarion/ Siemens Teamcenter (ALM ?PLM), Polarion TestRun, HP UFT, IBM Rational Functional Tester/ Rational Test Workbench/ Performance Tester, Parasoft Load Test, UserTesting, qTest Manager by QASymphony, Mockserver, Betamax, Borland Silk Perfomer, Automation Anywhere Testing Anywhere, TestPlant eggPlant, JUnit, MATALB, Simulink, Labview, JIRA, Mantis, Bugzilla, REDMINE, MISRA Rules QAC Checker, LINT, Klocwork, Coverity, PerlUnit, Test::Unit, Python, UnitTest++, QtTest, CppUtest, JUnit, TUX UTest, Tessy, IBM Rational Test Real Time (RTRT), Vector/CAN Tools (CANopen, CANoe, CANape & CANKing), etc.
• HARDWARE DEVELOPMENT TOOLS & LANGUAGES: ALTIUM, ORCAD & EAGLE (schematics, footprints & layouts), Hyperlynx (EMC/EMV), Modelsim, VHDL, Verilog, SystemC (FPGAs)/ Oscilloscope & Logic Analyzer
• MODELING & SIMULATION: MATLAB, Simulink, LabView, Ptolemy, Mentor Graphics ModelSim, Autodesk 3ds Max (3D Studio MAX), etc.