Biotech/Pharma/MedTech Consultant

1/2001 – 2/2024

PROFESSIONAL EXPERIENCE:

TEAM LEADING / VARIANT MANAGEMENT / PLANNING / COORDINATION / SYSTEMS ENGINEERING / PLM / ALM / POLARION SERVER ADMINISTRATION / ARTIFICIAL INTELLIGENCE, MACHINE LEARNING & DATA SCIENCE ENGINEERING / CONSULTANT / RESPOSITORY MGMT / COACH / ADVISOR
- 2023, Germany&Remote
- Project: AI Software Development (Artificial Intelligence/ Machine Learning / Deep Learning / Big-Data / Data Analysis / Data Science)
- Activities & Tools: Team Leading / Planning / Coordination / Coaching / Advising / Systems Engineering, POLARION Variant Management, Product Line Management, PLM – Product Lifecycle Management, ALM – Application Lyfecycle Management, Requirements Engineering, Testing Management and POLARION Administration & Server Administration/ Pure::Variants / Enterprise Architect / Python & R / Anaconda / PyTorch / TensorFlow / Systems Architecture / Machine Learning / Algorithmics / Data Science / Artificial Intelligence / Big Data / Neural Networks / Deep Learning / Cybersecurity / LLMs (Large Language Models) / Data Lakehouses / Software Architecture & Design / SysML / UML / BPMN / JIRA / Confluence / Framework Concept & Development / Programming-Coding / Testing / DevOps / Git Repository Management / Ansible / Ansible Playbook / Server AdministrationScikit-Learn / Zeppelin & Jupyter Notebooks / ONNX AI / Gitlab CI/CD / DVC (Data Version Control) / SQL / SCRUM / Agile / Kubernetes / Docker / HADOOP / Amazon AWS / Value Cloud / Celery / DJANGO / React – JavaScript / REST APIs / GitOps / Azure DevOps / Argo CD / GitHub / SUSE Linux / Unix / PuTTY / MobaXterm

PLANNING / SCRUM / COMPUTER SYSTEM VALIDATION / SYSTEMS ENGINEERING / QUALITY MANAGEMENT / GAMP 5 CSV / SOPs & WIs / BPMN / TEST MANAGEMENT
- 2022-2023, Germany&Remote
- End client: BioNTech SE (PHARMA)
- Tools: SCRUM / MS Office / Adonis BPM / GUS-OS ERP / SAP ERP / SOP-Guard /Alpega TMS / MS Navision / WinSped / MS Teams – Sharepoint / LabWare LIMS & ELN / MES
- Activities: Requirements Engineering / Requirements Management / Pharmaceutical Development & Production / Digitalization of Paper-Based Pharmaceutical Manufacturing Process / IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Performance Qualification) / Databases / GAMP5 CSV (Computer System Validation) ) / Cybersecurity / SAP Cutover Planning and Execution / Documentation Approvals / Regulatory Affairs / Write & Review SOPs (Standard Operating Procedures) & WIs (Working Instructions) / SCM - Supply Chain Management Testing / Test Management / Quality Control / Quality Management / Clinical Trials / SAP Introduction in the company / Multi-site / SW ERP Tool Change Cutover Planning and Execution / SW Tool Deployment (SAP ERP in Supply Chain Mgmt) / FMEAs / BPMN 2.0 (Business Process Model and Notation) / BPM (Business Process Management) / ADONIS BPM Suite / Risk Management / Ris Assessments / FMEAs / FTAs / HAZOP / Corona Virus Vaccine / individualized Neoantigen/mRNA/cancer Specific Immunotherapy (iNeST) / Monoclonal Antibody Therapies (Cancer, etc) - Pharma Product / Pharmaceutical Production / IFUs (Instructions for Use) & O&M (Operation & Maintenance Manuals) / Systems Engineering / Documentation / Training / DMSs SOP-Guard & SOP-Form/ Software / Changes / Databases / SQL / CAPAs / V-Model & SCRUM

TEAM LEADING / RISK MANAGEMENT / QUALITY MANAGEMENT / FMEA MODERATION & ISSUANCE / COORDINATION / SYSTEMS ENGINEERING
- 2022, Germany&Remote
- RISK & QUALITY MANAGEMENT, Artificial Intelligence, Machine Vision & Sensor R&D
- APIS IQ-RM Pro / DOORS / JIRA / Medini Analyze / PTC-MKS Integrity / Enterprise Architect
- FMEA Issuance and Moderation (SYS/SW/HW/MD) / Team Leading / Coordination / Systems Engineering / Cybersecurity / Risk Management / Requirements Engineering / Quality Management / Documentation / Coaching-Training / Safety Related Hardware, Mechanical Design, Software and System Level FMEAs / FTAs / Safety Analysis / C-C++ / VB.NET

TEAM LEAD / REGULATORY AFFAIRS / SYSTEMS ENGINEERING (+SW+HW+MD) / RISK MANAGEMENT / QUALITY MANAGEMENT / REQUIREMENTS MANAGEMENT / ALM- PLM CONSULTANT
- 2020 till End 2021, Ireland&Remote
- End client: MALLINCKRODT Pharmaceuticals (PHARMA & MedTech & Combination Products)
- 2 projects: Nitric Oxide pulmonary Delivery System (China registration) & Extracorporeal blood Photochemotherapy (ECP) / Photopheresis System
- Activities & Tools: FDA & China & EU Submissions, PMAs/IDEs/510Ks, Systems Engineering, Requirements Engineering & Management with JAMA, System Architecture (SysML, Enterprise Architect). Consulting for Variant Management- Product Line Management- ALM- PLM- Application Lifecycle Management: BigLever Gears and Pure::Variants. Documentation Review and Approval, Cyber-security, Patient Data Protection, HIPAA. IF: Regulatory Affairs, Risk Management, Quality Management, Usability-Documentation, Audits. Cross functional interfacing (Medical, Clinical, V&V, company management, Usability, RA, Legal, Marketing, Purchasing, Engineering, Quality, Risk Mgmt), stakeholder management, ALM/PLM Consultancy & Planning & Implementation, Systems Engineering, Requirements Engineering/Management, System Architecture, Software, Risk Management, Quality Management, Documentation, Reviews. DMS, V-Model, Microsoft Project, Enterprise Architect/EA/SysML/UML, JAMA ReqEng, listing of international standards, regulations and guidelines applicable to the project (including the conversion of clauses into design input requirements), gap analysis. Planning, Development, Qualification & Post-Martket. /
- ISO 13485:2016, 21 CFR/FDA, ISO 9001, MDD/IVD, MDR/IVDR, ISO 14971, EN 62304, EN 62366, CSV, GxP, GMP, GCP, GLP, GAMP, MES, LIMS. V-Model, SCRUM, Agile, Python, JAVA, JavaScript

TEAM LEAD / SYSTEMS ENGINEERING / QUALITY MANAGEMENT / RISK MANAGEMENT / GAP ANALYSIS
- 2020, Germany&Remote
- End client: KARL STORZ SE & Co.KG (MedTech)
- Project: Development and Clearance of a fully integrated Operating Theater for an Operating/Surgery Hospital Room
- Functions: ALM-PLM Consultancy&Planning&Implementation, Systems Engineering Leading / Risk Management Engineering / Regulatory Affairs Support / DMS / Clearance Support.
- Tools: Databases, SQL, VB.NET, JAVA, Labview, C# & Testing tools, Linux OS, RTLinux OS, Siemens Polarion & Teamcenter ( ALM – PLM ) / FDA & EU Submissions
- Know-How: OOD, OOP, Video Processing, Streaming, Network protocols, SaMD (Software as a medical device), IEC 60601, MDD/IVD, MDR/IVDR, ISO 14971, AAMI TIR32, AAMI TIR57, 21 CFR 820, ISO 13485, IEC 6230, SysML, V-Model, Scrum, Agile

LEAD AUDITOR: MEDICAL DEVICES & PHARMA / QUALITY MANAGER
- 2019-2020: Switzerland, France, Hungary and UK + Germany. (&Remote)
- End Client: HAEMONETICS (PHARMA & MedTech & Combination Products)
- Blood Filtering Systems, Blood & Plasma Collection Systems & Blood Management Systems
- SOFTWARE & HARDWARE / Quality Management / Several Audits as Lead Auditor / 1st and 2nd party Audits of Medical Device / Pharma / Combination Products companies, Supplier Audits, Internal Audits, mock-up Audits (CE Marking, MDSAP, preparation for Notified Body Audits), IFA SISTEMA FS SW
- ISO 13485:2016, MDSAP, GMP, GCP, GLP, GAMP 5, SaMD (Software as a Medical Device), 21 CFR/FDA, ISO 9001, MDD/IVD, MDR/IVDR, ISO 14971, EN 62304, EN 62366, IEC 61508, EN60204, NFPA79, UL2011, ISO 13849

RISK MANAGEMENT LEAD / SAFETY ASSURANCE CASES LEAD / REQUIREMENTS MANAGEMENT / QUALITY MANAGEMENT / REGULATORY AFFAIRS
- 2017-2018, Germany & Switzerland &Remote
- End Clients: YPSOMED & ROCHE DIABETES CARE (PHARMA & MedTech & Combination Products)
- Project: Development and Market Clearance (especially USA/FDA and EU) of different Insulin Infusion Pump Systems / Auto-injectors & Pens / SaMD (Software as a Medical Device)
- MEDICAL TECHNOLOGIES (Class 2 device) and PHARMA (Combination Products)
- Function: Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / Risk Manager / Risk Assessments / Supplier Management / Safety Assurance Cases / Quality Engineer / Requirements Engineer
- Tasks/Goals/Tools/Skills: Risk Management Lead / FDA & EU Submissions (PMAs/510Ks/IDEs/CE-Mark) / Resource planning / Introduction of Software tools in the company / Coordination of external partners and internal teams / Budgeting / Risk Management / ALM-PLM Consultancy&Planning&Implementation / CSV (Computer System Validation) / DMS / Perform Safety Assurance Cases (SACs) – including Cyber-Security - / Active products : Software, Hardware & Mechanical Design / SIEMENS MES, SIEMENS Opcenter, DMS, Labware LIMS, Preliminary Hazard Lists and Analysis, Risk Analysis, FTAs and FMEAs; HIPAA, DHF, DMR & DHR, SwissMedic; SACsbased on “Infusion Pumps Total Product Life Cycle, Guidance for Industry and FDA Staff” (December 2, 2014). RIMS / Additional norms/guidances/papers applied/used: Papers on cybersecurity, ISO 14971 / ISO 15026 / MDD, MDR / AAMI TIR32 / AAMI TIR57 / 21 CFR 820 / ISO 13485 / LIMS Labware / IEC 62304 / IEC 60601 / WiFi / Audits. Listing of international standards, regulations and guidelines applicable to the project, conversion of clauses into design input requirements (including assessment), gap analysis, CAPAs, interaction with the development and Regulatory Affairs teams; introduction of an appropriate SW tool for SAC performance; support of the introduction of the SAC work product and process into the company lifecycle; Cyber-Security; compilation of the Risk Management File (RMF), Java, JavaScript, Python, Angular & Testing tools / V-Model, Agile, Scrum, UML, SysML / LabWare LIMS & ELN, MES SAP, Siemens Polarion & Teamcenter ( ALM – PLM ), Google Cloud / Databases / SQL, DOORS, Turbo-AC, GLP, GxP, Papers on cybersecurity, transition MDD/IVD to MDR/IVDR, GAMP5, Computer System Validation (CSV), ServiceMax, etc.

SYSTEMS ENGINEERING LEAD /QUALITY MANAGEMENT / GAP ANALYSIS / REGULATORY AFFAIRS / COORDINATION/ TESTING
- 2016-2017
- End Client: ZIMMER BIOMET (MedTech)
- Project: Submission & Audit & Development & DHF (Design History File) Remediation Activities: minimal-invasive surgery robot (electro-mechanical device) - innovative high-precision brain & spine SURGERY.
- MEDICAL TECHNOLOGIES (Class 2b device)
- SaMD (Software as a medical device), FDA 510k submission, 93/42/EEC, FDA & EU Submissions, transition MDD/IVD to MDR/IVDR, 2007/47/EC, GAMP5, Java, JUNit, Labview, SAP, C#, Matlab Simulink, C++,Perforce, GLP, GxP, CSV (Computer System Validation), 93/42/EEC, 2007/47/EC, 2016/MDR (Medical Device Regulation), / Regulatory Affairs / Project Management / DMS / Cyber-Security / Clearance Support / Systems Engineering / Risk Management / RIMs / Quality Engineering / Testing / Post-market / Clinical Evaluation / Clinical Trials / EN ISO 13485(Quality Management), EN ISO 14971 (Risk Management), EN 62304 (Software Lifecycle), HIPAA, Usability (EN 62366 & EN 60601-1-6), FDA 21 CFRs 211, 820, 803 and 806, Patient Data Protection

PROJECT MANAGER / SYSTEMS LEAD / RISK MANAGER / FUNCTIONAL SAFETY MANAGER-ENGINEER / TEAM LEAD
- 2014-2016, GERMANY&Remote
- SAFETY CRITICAL SYSTEMS.
- Tools: Medini Analyze, APIS IQ, PTC Integrity and ReqEng, Subversion, MS Project, IBM DOORS, Enterprise Architect, MS Visio, Power Point, Excel, Scrum.
- Audits, Presentations, coaching of development; checklists, templates and process definition.
- FMEA (and FMEDA) Issuing&Moderation, ISO 26262, IEC 61508, Java, Javascript, Labview, C#, Matlab Simulink, C++, EN60204, NFPA79, UL2011, ISO 13849
- Depending on the project, responsible, author, coordinator, reviewer and/or co-authour of different work products or responsible for the whole FuSa Lifecycle: Hazard%Risk Analysis, Safety Concepts, FuSa effort estimation, customer contact, Functional Safety Plan, Impact Analysis, FMEA, FMEDA, FuSa Test Specs, Safety Case, FuSa Assessments, etc.

SYSTEMS ENGINEERING LEAD / REGULATORY AFFAIRS / QUALITY MANAGEMENT / AUDITS / SYSTEM ARCHITECTURE / REQUIREMENTS ENGINEERING
- 2013-2014.
- End Client: B. BRAUN (PHARMA & MedTech & Combination Products)
- Project: Audits / DHF Remediation activities / Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / FDA-clearance (PMAs/510Ks) and improvement of existing Infusion Pump Systems.
- MEDICAL TECHNOLOGIES – DMS, Polarion, Supplier Management , RIMS, 21 CFR 820 / ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / SIEMENS MES, SIEMENS Opcenter / WiFi / FDA clearance-approval process - FDA 21 CFR 803 / Cybersecurity / CSV / STARLIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / FDA 21 CFR 806 / Total Product Life Cycle, test case / DHF, DMR & DHR / Audits / CAPAs / Optics / SQL, Java, JavaScript, GLP, GxP, CSV (Computer System Validation) / Patient Data Protection
- Function: Requirements Engineering / Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management / V-Model / Agile / SCRUM / SysML / HIPAA (Health Insurance Portability and Accountability Act)

SCRUM MASTER / REQUIREMENTS ENGINEERING-MANAGEMENT / QUALITY MANAGEMENT / TESTING / RISK MANAGEMENT
- 2012-2013.
- End Client: ROCHE Diagnostics (MedTech & PHARMA)
- Project: IVD Device - New Development of the to date highest throughput medical in-vitro diagnosis for different diseases (COVID, HIV, Hepatitis, etc.) based on PCR technology.
- MEDICAL TECHNOLOGIES -Audits / HL7 / LIMS / C# / Scrum / V-Model / Google Cloud / Databases / SQL / Function: Requirements Engineering / Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management / V-Model / Agile / SCRUM / SysML / / HIPAA / Patient Data Protection / ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / EU & FDA clearance-approval process / FDA 21 CFR 820 / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / FDA 21 CFR 803 & 806.

TECHNICAL PROJECT MANAGER (Engineering Product Leader - EPL), RISK MANAGER, FUNCIONAL SAFETY PROJECT LEAD and TEAM LEADER OF THE FUNCTIONAL SAFETY SW-DEVELOPMENT TEAM
- 2011-2012, Southern Region, GERMANY. (/remote)
- MS Project, IBM DOORS, MS Visio, MS Power Point, MS Excel, Atlassian JIRA & Confluence, Enterprise Architect / ISO 26262, Automotive SPICE, AUTOSAR 4, FlexRay, CAN, Python.
- Engineering Project Manager (composed of HW-Team, SW-Team, Mech-Team, Test and Validation Teams, …), team of ca. 60 people. Multi-cultural and multi-location team (6 locations in different countries).
- Audits, Scrum, Functional Safety (ISO 26262) project leader (HW+SW) & Team Leader/Functional Owner of the FuSi-SW-Development team (ca. 8 people). Multi-location / remote team (4 locations) / C, C++, VxWorks OS, DSP, CppUTest

QUALITY MANAGEMENT / QUALITY ASSURANCE TEAM LEAD / ASSESSMENT PREPARATION
- 2011, GERMANY&Remote
- Audits, MS Project, MS Power Point, IBM/Telelogic Rational DOORS
- Multisite (& multi-country) Team Leading. Goal of the Project: Process Improvement of a multi-site development as preparation for an Assessment. Disciplines: Requirements Management, Version Control Management, Change Management, Software Development and Testing. Typical Tasks: organization of meetings and workshops (with engineers, quality managers and discipline managers), chair meetings, prepare presentation slides, hold presentations, write down minutes, hold presentations and trainings, slide preparation, business trips to sites in other countries, project planning, process analysis, coordination, arrive to agreements among the different teams, commissioning, Action Item List creation and management / C, C++, VxWorks OS, Microcontrollers, IEC 61508, ISO 26262, EN60204, NFPA79, UL2011, ISO 13849

SOFTWARE DEVELOPER / TESTER / REQUIREMENTS ENGINEERING / SW DESIGN&ARCHITECTURE
- 2010-2011, Northern Region, GERMANY&Remote
- SAFETY CRITICAL SYSTEMS.
- Video-processing, Scrum, DSP, OpenGL, Adobe Video libraries, C, C++, Qt, Microsoft Windows RT OS, Perl , PerlUnit, Test::Unit, Python, UnitTest++, QtTest

REQUIREMENTS MANAGER -HP QUALITY CENTER- AND SYSTEMS & SW ARCHITECT
- 2010-2011, SWITZERLAND.
- End Client: METTLER-TOLEDO (MedTech)
- Project: Precision electronic system for liquid-powder mixing to be used in the Pharma Industry and Medical Research / HP Quality Center / Cybersecurity / CSV / LIMS / DMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / LabWare LIMS / Test Case Derivation, Development, Execution and Reporting / SIEMENS MES, SIEMENS Opcenter / V-Model / Agile / SCRUM
- PHARMA / MEDICAL TECHNOLOGIES / WiFi / PRECISION MEASUREMENT ELECTRONICS.
- Function: Audits / Requirements Engineering / Regulatoy Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management

SOFTWARE ARCHITECTURE & DESIGN, REQUIREMENTS, PROGRAMMING, TESTING / QUALITY MANAGEMENT
- 2009-2010, GERMANY.
- End Client: SIEMENS HEALTHCARE (MedTech)
- Project: IVD Device / Development of a medical in-vitro device for the diagnosis of blood coagulation through optical technology.
- MEDICAL TECHNOLOGIES / Audits / SAFETY CRITICAL SYSTEMS / PRECISSION MEASUREMENT ELECTRONICS / OPTICAL TECHNOLOGIES / LIMS / ELN / FPGA Xilinx / Xilinx MicroBlaze/ Python / C++ / C / MATLAB / MATLAB xUnit Test Framework / LabVIEW / LabVIEW Unit Test Framework / VI Tester / Caraya / InstaCoverage / Scrum

SALES / PURCHASING / IMPORT-EXPORT BUSINESS AGENT / BROKER
- 2008, Independent Agent.
- IMPORT-EXPORT BUSINESS
- Languages, People & Soft Skills, Communicability, International Relationships Management, Wide Cultural and interdisciplinary skills, Strategic thinking, Client and Partner acquisition and care, Marketing Techniques, Marketing through Internet, Email, Frequent Phone Calls and Meetings, VoIP, MS Office, MS Project.


SYSTEMS ENGINEER / SOFTWARE ARCHITECT + SOFTWARE DEVELOPER + TEAM LEAD
- 2004-2008, GERMANY.
- Company: FRAUNHOFER INSTITUTE IPMS (Dresden)
- Communications Technology & Video-Technology & MEDICAL TECHNOLOGIES (MedTech), Verilog, SVUnit, Vunit, C, C++, MATLAB, Unit++, Matlab xUnit, matlab.unittest, Scrum

OTHER FORMER ROLES
• 2004. GENETICS / BIOLOGY / BIO-LAB / MEDICAL STATISTICS / BIOSTATSTICS / BIOELECTRONICS. UAEM University and Ecology Institute of Xalapa, Mexico. ROLE: Research Bio-Engineer / GxP / GCP / GLP / GCLP.
• 2003. ELECTRONICS FOR RESEARCH ON PHYSICS / PRECISION MEASUREMENT ELECTRONICS. CERN (European Organization for Nuclear Research), Switzerland. ROLE: Hardware Designer & Developer / VHDL, Vunit, C, C++, MATLAB, Unit++, Matlab xUnit, matlab.unittest
• 2002-2003. Development Engineer / Test-To-Speech Technology (TTS) / Company: Fraunhofer Institute IIS (research institute that developed and owns the patent of the MP3 audio format), Erlangen, GERMANY. Development of an OS-independent, multi-language, universal, flexible, light upgradable Software Speech Module for an Information System. C, C++, xUnit++, JavaScript, JSUnit, Python
• 2001-2002. Universidad Politécnica de Valencia (UPV), Spain. Fields: OPTICS RESEARCH / MODELLING & SIMULATION.

Embedded Entwicklung / hardwarenahe Entwicklung, FMEA (Failure Mode and Effects Analysis), Forschung & Entwicklung (allg.), Projektleitung / Teamleitung, Projektmanagement - Risikomanagement, Projektmanagement (IT), Qualitätsmanagement / QS / QA (IT), Regulatory Affairs Management, Risikomanagement, Systems Engineering, Technische Projektleitung / Teamleitung, Testing (IT)