Profil
- Senior Systems Engineer und Requirements Engineer mit 25 Jahren Berufserfahrung in hochregulierten Branchen: Medizintechnik, Pharma/Biotech, Automotive (funktionale Sicherheit) und Sondermaschinenbau. Durchgängige Praxis über den gesamten Produktlebenszyklus - von Anforderungen und Architektur über Implementierung und V&V bis zu Zulassung, Produktion und Betrieb.
- Methodische Tiefe: Requirements Engineering (IREB-zertifiziert seit 2010) mit Polarion (inkl. Administration), IBM DOORS (+DXL) und JAMA; MBSE und Systemarchitektur (SysML/UML, Enterprise Architect, MagicDraw); Risikomanagement nach ISO 14971 und ISO 26262 inkl. FMEA-Moderation (APIS IQ); Qualitäts- und Compliance-Praxis (GxP/GAMP 5 CSV, ISO 13485 Lead Auditor, MDR/IVDR-Kontext); Variant Management (BigLever GEARS, Pure::Variants).
- Ergänzend: technische Projekt- und Teamleitung (Workshops, Stakeholder-Management, Lieferantensteuerung), SAP-S/4HANA-Transformations- und Cutover-Erfahrung sowie aktuelle KI-/GenAI-Praxis (LLM-basierte Lösungen, Datenpipelines, ~100 bewertete/umgesetzte Use Cases 2024?2026). Deutsch und Englisch verhandlungssicher; sofort verfügbar, remote/hybrid bundesweit.
SCHLÜSSELKOMPETENZEN
Systems Engineering & Architektur:
- Systemarchitektur, Dekomposition und Integration komplexer sicherheitskritischer Produkte über Mechanik, Elektronik und Software.
MBSE (SysML):
- Modellbasiertes Systems Engineering
- SysML-/UML-Modellierung in Enterprise Architect und MagicDraw
- Architektur-Konsistenz und modellbasierte Dokumentation
Requirements Engineering & Management:
- Erhebung, Strukturierung, Management und Traceability - Polarion (inkl. Administration), IBM DOORS (+DXL), JAMA; IREB-zertifiziert
- Requirements-Workshops und Stakeholder-Konsolidierung
Schnittstellendefinition & Integration:
- Schnittstellenspezifikationen und Systemintegration über Mechanik, Elektronik und Software
- Bussysteme und Sensorik
Verifikation & Validierung:
- V&V-Planung, -Durchführung und -Nachweise
- Testmanagement (HP QC/ALM, Jira/Xray-Kontext)
- Traceability Anforderung ? Risiko ? Test
Risikomanagement & Funktionale Sicherheit:
- ISO 14971 (Leitung/Moderation) und ISO 26262 (AFSP-Qualifikation SGS-TÜV Saar)
- FMEA-/FMEDA-Moderation und -Erstellung (SYS/SW/HW/MD)
- Safety Cases
Qualität & Compliance:
- GxP/GAMP 5, Computer System Validation (CSV), ISO 13485 Lead Auditor (BSI-geschult), MDSAP, MDR/IVDR- und 21-CFR-Kontext
- Design History Files, SOPs/WIs
Technische Projekt-/Teamleitung:
- Technische Projektleitung
- Koordination interdisziplinärer Teams
- Lieferanten-/Partnersteuerung
- Eskalations- und Stakeholder-Management
- Entscheidungsvorlagen
SAP-/Enterprise-Transformation:
- S/4HANA-Programm-Praxis (BioNTech/Pfizer):
- Datenmigration
- Cutover-/Go-live-Planung
- Hypercare
- MES-/SAP-/LIMS-Schnittstellen
- ERP-Harmonisierung
KI / GenAI:
- LLM-basierte Lösungen und Datenpipelines in Produktions- und Engineering-Kontexten
- ~100 Use Cases bewertet/umgesetzt (2024?2026); EU-AI-Act-Kontext
TOOLS & METHODEN
MBSE / Modellierung:
- SysML (Enterprise Architect, MagicDraw)
- UML
- Use Cases
- modellbasiertes Design
- MID Innovator
Anforderungen / ALM:
- Polarion (inkl. Administration)
- IBM DOORS (+DXL)
- JAMA
- Baselines & Traceability
- Codebeamer-Kontext
Sicherheit & Risiko:
- ISO-26262-Arbeitsprodukte
- APIS IQ (FMEA/FMEDA)
- ISO 14971
- FTA
- Safety Cases
V&V & Test:
- V&V-Planung
- HP Quality Center/ALM
- Testmanagement
- Jira/Xray-Kontext
- Integrationstests
- Log-Analyse
Varianten/Konfiguration & PLM:
- BigLever GEARS
- Pure::Variants
- Windchill
- Teamcenter
- Produktdaten-/Konfigurationsmanagement
Qualität & Compliance:
- GAMP 5 / CSV
- URS/FS
- ISO 13485/MDSAP-Audits
- MDR/IVDR
- 21 CFR Part 11
- DHF/SOPs/WIs
Prozesse & Modellierung:
- BPMN
- Prozessanalyse und -optimierung
- MS Visio
- Ist-/Soll-Analysen
SAP / Produktions-IT:
- S/4HANA-Programm-Praxis
- MES-/LIMS-Schnittstellen (Opcenter-/PAS-X-Kontext)
- Datenmigration & Cutover
Programmierung & Daten:
- Python (täglich)
- C/C++
- SQL
- Git/CI-CD
- Docker
- Datenpipelines und Auswertungen
KI-Tools:
- LLM-Integration (u. a. GPT/Claude)
- RAG-Ansätze
- Microsoft 365 Copilot (hands-on)
- Prompt-Engineering
Zusammenarbeit:
- Jira
- Confluence
- Azure DevOps
- MS Project
- agil (Scrum-Praxis) & klassisch
SKILLS & TECHNOLOGIEN- PROJECT MANAGEMENT/ TEAM LEADERSHIP:
- project planning and tracking, Scrum / Agile, stakeholder management, meeting and workshop organization and chairing, action-point-list generation and tracking, preparation of presentations & presentation skills, cost calculation and budgeting, SAFe, soft skills, external resource acquisition & interviewing, multi-site international team coordination, commissioning.
- MEDICAL TECHNOLOGIES/ PHARMA/ BIOTECH ? REGULATIONS, SPECIFICATIONS & LAWS (applied and theoretical knowledge):
- GxP / GMP, GAMP 5, CSV (Computer System Validation), EN ISO 13485 (Quality Management), EN ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle), FDA 21 CFR Part 820, MDR 2017/745 (Medical Device Regulation), Design / Quality / Regulatory Affairs, GCP / GLP, 510(k) submission, Usability (IEC 62366 & EN 60601-1-6), IVDR, FDA 21 CFR Part 11, IEC 60601, CSA (Computer Software Assurance), Data Integrity (ALCOA+), 93/42/EEC & 2007/47/EC, FDA 21 CFR 58 & 211, HL7 / DICOM / LOINC, Digitalization & toolchain/ALM/PLM coaching, process documentation, FDA 21 CFR 803 & 806, ISO/IEC 15026-2, ISO 9001 / ISO 9003, GEP / GCLP / GDP, IEC 12207, IEC 61508, ISO 61010.
- REQUIREMENTS ENGINEERING:
- requirements elicitation, analysis & negotiation, specification and modeling (SysML/UML), requirements management & traceability, IREB CPRE certified, template creation, requirements reviews, variant management for Requirements Engineering, DXL scripting, structured decomposition (customer ? system ? HW/SW).
- ARTIFICIAL INTELLIGENCE/ MACHINE LEARNING/ GENERATIVE AI / AGENTIC ENGINEERING:
- Generative AI & LLM application development (OpenAI GPT, Anthropic Claude, open-source Llama/Mistral), RAG (Retrieval-Augmented Generation), Machine Learning & Data Science, Python AI stack (PyTorch, TensorFlow, Scikit-Learn), NLP & question-answering, Agentic Engineering & AI agents (LangChain, LangGraph, MCP ? Model Context Protocol), prompt engineering & structured outputs (JSON/schemas), embeddings & vector databases (Qdrant, pgvector, Elasticsearch), Deep Learning / Neural Networks, clinical decision support (evidence-based QA for clinicians), multi-agent orchestration (AutoGen, PydanticAI), tool/function calling, hand-over, guardrails & human-in-the-loop, AI evaluation (RAGAS, hallucination/safety/helpfulness metrics), LLMOps & observability (LangSmith, Logfire), MLOps & DVC, Big Data / Data Lakehouses, Hugging Face transformers, medical statistics & biostatistics, AI-assisted, Spec-Driven Development (Claude Code, Cursor, GitHub Copilot), CAG (Cache-Augmented Generation), hybrid search & reranking, computer vision (object detection), entity linking & annotation pipelines, AI regulation & governance: EU AI Act, ISPE GAMP 5 AI Guide, FDA GMLP, AI in GxP, Power Platform AI Builder & Copilot Studio, ONNX.
- MES / LIMS / ELN / ERP ? DIGITALIZATION & PHARMA 4.0:
- MES (Manufacturing Execution Systems) for MedTech/Pharma/BioLabs ? Siemens Opcenter, LIMS ? LabWare, STARLIMS, ELN (Electronic Lab Notebooks), SAP S/4HANA & SAP ERP, GAMP 5 CSV of MES/LIMS/ELN systems (URS/FS/DS, IQ/OQ/PQ), Rockwell MES, shopfloor digitalization / Pharma 4.0, ERPs, Supply-Chain & Warehouse Management (SAP, GUS), DMS (Document Management Systems), Minitab.
- R&D, MODELING, SIMULATION, SYSTEM & SW & HW DESIGN/ARCHITECTURE & PROGRAMMING TECHNIQUES:
- SCRUM / Agile / V-Model, SysML & UML modeling, OOA, OOD, OOP (object-oriented analysis, design & programming), architecture & design patterns, algorithmics, databases, model-driven development & automatic code generation, prototype programming, feasibility analyses & project evaluation, HMI development (Human-Machine Interface), usability & UI/UX, AUTOSAR 4, reverse engineering, Virtual Reality (VR) / Augmented Reality (AR), IxDF (Interaction Design Foundation) methods, scientific instrumentation, optics research.
- QUALITY MANAGEMENT / PROCESS:
- ISO 13485, audits (internal, external, supplier), Risk Management, GxP / GMP / GAMP 5 / CSV, FMEA issuing and moderation, DHF, DMR & DHR development and remediation, CAPA & NC (non-conformity) management, Change Control & Document Control, QMS integration, Supplier Quality & Supplier Management, V-Model, SCRUM and Extreme Programming/Agile in regulated contexts, process-improvement project management & assessment preparation, A-SPICE (Automotive SPICE) process improvement, regulatory-authority support, shopfloor optimization, international multi-site development scenarios, reporting, GCP / GLP.
- RISK MANAGEMENT & FUNCTIONAL SAFETY & CRITICAL SYSTEM DESIGN (MedTech, Pharma, Automotive):
- Risk / Functional Safety Manager, Engineer & Project Leader roles, ISO 14971, ISO 26262, risk and hazard analysis, FMEA / FTA / FMEDA, IEC 61508, Functional Safety Plan, Technical Safety Concept specification (requirements & architecture), FuSa V&V (testing), Functional Safety SW-implementation team leadership, DIA (Development Interface Agreement), Safety Assurance Cases, cybersecurity risk analysis, FuSa HSI.
- QUALITY ASSURANCE & TESTING:
- CSV (Computer System Validation), test planning & test management, automated & managed testing, verification planning, regulated (V-Model, waterfall), Agile and mixed development environments, unit testing, HIL / SIL, test strategy, test-case design/derivation, implementation and reporting, test & validation coordination, regression testing and automation, code reviews and static rule checking, endurance / long-term testing, defect-tracking tools, client-facing communication & customer service, creativity in the testing and mitigation process; wrap-around development & testing processes.
- BUSINESS MANAGEMENT:
- international relations, client & partner acquisition & care, presentation & people skills, contract negotiation, marketing, purchasing, tax systems.
- HARDWARE DEVELOPMENT & TESTING:
- PCB schematics and layout (plus component footprints), EMC/EMV, FPGA development, laboratory testing experience, hardware-near testing.
- MICROPROCESSORS:
- Texas Instruments SoCs & DSPs, NVidia SoCs and GPUs, ARM7 / ARM9 / ARM11 / Cortex A15 / Cortex M4, XILINX SoCs & Microblaze, ALTERA SoCs, Infineon TriCore & Aurix, Mobileye EyeQ, TI Jacinto & OMAP 5, Freescale ColdFire, Renesas SH-4.
- EMBEDDED OPERATING SYSTEMS:
- RTOS and non-RTOS, Embedded Linux, QNX, OSEK, MS WinCE, Express Logic ThreadX, Texas Instruments DSP BIOS, Freescale MQX, very-low-resource systems without embedded OS (bare metal).
- AREAS OF SPECIALIZATION IN SYSTEMS DEVELOPMENT:
- ?Pharma production facilities, minimally invasive surgical electro-mechanical devices (robots) for brain/spine surgery, electronic blood infusion pumps, in-vitro diagnostics, MRT device, X-ray device, video cameras for medical appliances, pharma and medical research electronic devices, bioelectronics & bio-lab devices, communication systems.
TOOLS- TEAM LEADING, PROJECT MANAGEMENT & OFFICE APPS:
- MS Office (Word, PowerPoint, Excel, Access, Visio), JIRA & Confluence, MS Project, Azure DevOps, Microsoft Team Foundation Server (MS TFS), ERPs and Warehouse Mgmt (SAP, GUS), Actano RPLAN e3, Mindjet MindManager.
- RISK MANAGEMENT, FUNCTIONAL SAFETY & QUALITY MANAGEMENT:
- APIS IQ-SW / IQ-RM, GessNet Turbo-AC, KPIT Medini Analyze, Plato FMEA, Coverity, Method Park STAGES, LINT, QAC, Polyspace, Klocwork.
- PHARMA / BIOTECH / MEDICAL / LAB:
- Siemens Opcenter MES, LabWare LIMS & ELN, MES for MedTech/Pharma/BioLabs, STARLIMS, Rockwell MES, Minitab, SAP S/4HANA.
- AI / GENERATIVE AI / LLM / AGENTIC ENGINEERING:
- OpenAI (GPT), Anthropic Claude, LangChain & LangGraph, MCP (Model Context Protocol) servers, Claude Code, Cursor, GitHub Copilot, Hugging Face, open-source LLMs (Llama, Mistral), AutoGen & PydanticAI, vector databases: Qdrant, pgvector, Elasticsearch, RAGAS, Power Platform (AI Builder, Copilot Studio), PyTorch, TensorFlow, Scikit-Learn, LangSmith & Logfire (LLMOps/observability), DVC (Data Version Control), ONNX AI, Flowise, OpenSpec (Spec-Driven Development).
- REQUIREMENTS ENGINEERING:
- IBM DOORS (+ DXL), Polarion (incl. administration), JAMA, Pure::Variants and BigLever GEARS for Variant Management, MKS/PTC, HP Quality Center, Borland Caliber, Orcanos QPack, Banana Scrum, HOOD DESIRe.
- PROCESS DEFINITION, MODELING & SIMULATION, ALM/PLM, VERSION/CHANGE/CONFIGURATION/VARIANT MGMT, ARCHITECTURE & DESIGN:
- BPMN (Business Process Model & Notation) & ADONIS BPM & ADOIT Suite, SysML/UML: SparxSystems Enterprise Architect, MS Visio, Polarion / Siemens Teamcenter (ALM?PLM), GIT, IBM Rational Rhapsody, MKS / PTC Integrity, Atlassian tools (JIRA etc.), pure::variants & BigLever Gears, Jenkins, MID Innovator & StarUML, Perforce P4V, Subversion and CVS, MAVEN, IBM Rational Rose, Telelogic-IBM ALM tool-chain, Serena Team Track & PVCS.
- SOFTWARE DEVELOPMENT ENVIRONMENTS, PROGRAMMING LANGUAGES & INTEGRATION:
- C/C++ & embedded C/C++, Python & R, PyTorch, TensorFlow, Scikit-Learn, SQL, JavaScript / React, REST APIs, Docker, GitHub / GitLab CI/CD, C#, Java, MATLAB & Simulink, LabView, Kubernetes, DJANGO & FastAPI, Anaconda, Jupyter & Zeppelin Notebooks, Amazon AWS, Google Cloud & Azure, MS Visual Studio, Streamlit, Celery, DVC, HADOOP, GitOps / Argo CD, Tableau, Eclipse & Xilinx SDK, TI Code Composer Studio & IAR Embedded Workbench, Qt, ONNX AI, NVidia GPUs, Doxygen, VBScript, Delphi & PHP, Looker, Freescale CodeWarrior, ARM RealView Dev Suite, Tcl/Tk, OpenGL (ES) API, Adobe Flash Lite, Value Cloud.
- QA/ TESTING:
- HP/MicroFocus Quality Center, Polarion TestRun / Siemens Teamcenter (ALM?PLM), JIRA, GIT, HP UFT, JUnit, MISRA Rules QAC Checker, LINT, Klocwork, Coverity, Vector/CAN tools (CANopen, CANoe, CANape & CANKing), IBM Rational Functional Tester / Test Workbench / Performance Tester, Parasoft Load Test, qTest Manager (QASymphony), Mantis, Bugzilla, REDMINE, UnitTest++, QtTest, CppUtest, Tessy & IBM Rational Test Real Time (RTRT), UserTesting, Mockserver & Betamax, Borland Silk Performer, Automation Anywhere Testing Anywhere, TestPlant eggPlant, PerlUnit / Test::Unit / TUX UTest.
- HARDWARE DEVELOPMENT TOOLS & LANGUAGES:
- ALTIUM, ORCAD & EAGLE (schematics, footprints & layouts), Oscilloscope & Logic Analyzer, VHDL & Verilog, ModelSim, Hyperlynx (EMC/EMV), SystemC (FPGAs).
- MODELING & SIMULATION:
- MATLAB & Simulink, LabView, Ptolemy, Mentor Graphics ModelSim, Autodesk 3ds Max (3D Studio MAX).
BerufserfahrungSENIOR SYSTEMS ENGINEER
FERNRIDE / CLAAS / Casculate (Autonome Mobilität & Sondermaschinen), Deutschland / Remote
- MBSE / ANFORDERUNGEN (POLARION), SICHERHEITSKRITISCHE MASCHINEN
- Modellbasiertes Systems Engineering für komplexe sicherheitskritische Produkte.
- Modellbasiertes Systems Engineering / Requirements Engineering in Polarion mit V&V, Risiko-/FMEA-Management.
- Konsistenz der Systemarchitektur und Anforderungs-Traceability; Polarion-Administration.
- Schnittstellendefinition und Systemintegration über HW/SW/Mechanik.
- Bereichsübergreifende Zusammenarbeit mit Mechanik-, Elektrik- und Software-Teams.
- Verifikations- & Validierungsmanagement; Test- und Freigabekonzepte.
- MBSE-Integration in den Entwicklungslebenszyklus; Prozessdefinition.
SYSTEMS ENGINEER (SysML / ENTERPRISE ARCHITECT) & REQUIREMENTS ENGINEER (JAMA) - MEDIZINPRODUKTE
MALLINCKRODT (Medizintechnik/ Pharma), Irland
- Extrakorporale Photopherese- und NO-Beatmungssysteme - HW/SW/MD-Integration.
- MBSE-Modellierung mit SysML in Enterprise Architect; Systemarchitektur und Dekomposition.
- Requirements Engineering und -Management in JAMA; Zerlegung in gemeinsame/varianten-/sicherheitsrelevante Anforderungen.
- Schnittstellendefinition und Systemintegration von Pumpen, Sensorik, Software und Disposables.
- Risikomanagement (ISO 14971); Traceability Anforderung ? Risiko ? Test.
- Verifikations- & Validierungsplanung und -nachweise.
- Bereichsübergreifende Arbeit mit Mechanik, Elektrik, Software und Regulatorik.
ZIMMER BIOMET (Medizintechnik), Frankreich
- SYSTEMARCHITEKTUR, ANFORDERUNGEN & V&V (IEC 62304) ? CHIRURGIEROBOTIK
- Chirurgische Robotersysteme für Hirn- und Wirbelsäulenchirurgie.
- Systemarchitektur und HW/SW/MD-Integration für Robotersysteme.
- Anforderungsmanagement nach IEC 62304; DHF; strukturierte Dekomposition.
- Verifikation & Validierung; Traceability Anforderung ? Risiko ? Test.
- Schnittstellendefinitionen über Mechanik, Elektronik und Software.
- Design-Reviews und QMS/RA-Zusammenarbeit.
- Modellbasierte Ansätze (SysML/UML).
HELLA (Automotive / F&E), Deutschland
- REQUIREMENTS ENGINEERING (IBM DOORS) & FUNKTIONALE SICHERHEIT ? KOMPLEXE SYSTEME
- Anforderungen und funktionale Sicherheit für Sensor- & Vision-Systeme.
- Requirements Engineering mit IBM DOORS; Systemmodell-Updates und Traceability.
- Funktionale Sicherheit ISO 26262; FMEA-Moderation.
- Schnittstellenspezifikationen; hardwarenahes Testen.
- Disziplinübergreifende Koordination (Sensorik, Software, Produkt).
- Machbarkeits- und Risikoanalyse.
- V&V-Unterstützung.
KARL STORZ (Medizintechnik), Deutschland
- ALM/PLM-BERATUNG (POLARION) · SYSTEMSPEZIFIKATIONEN - MEDIZINPRODUKTE
- Minimalinvasive / OP-Systeme ? eingebettete HW/SW-Integration.
- ALM/PLM-Beratung mit Polarion (inkl. Administration).
- Systemspezifikationen für komplexe Geräte; Use Cases / BPMN.
- Requirements Engineering, Test/Verifikation.
- Risiko- und Systemspezifikationsmanagement.
- Bereichsübergreifende Zusammenarbeit F&E/QA/RA.
- Traceability und Reviews.