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Letztes Update: 28.03.2024

MedTech/Pharma/Biotech Risk&QM&Reqs Mgr-Engineer/Team-Project Lead / SYS & SW & HW Architect

Firma: As GmbH, Ltd, S.A. or as Freelancer
Abschluss: MSc - Master’s Degree (5-year worldwide accepted University program) in Engineering – 2 Specialties, 2002, UPV Valencia, Spain
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (verhandlungssicher) | englisch (verhandlungssicher) | italienisch (verhandlungssicher) | spanisch (Muttersprache)

Dateianlagen

2023-12-13-CV-LifeSciences-MIX-SysEng-ReqEng_131223.docx
2023-12-13-CV-LifeSciences-MIX-SysEng-ReqEng_131223.pdf
2023-11-CV-Automotive_131223.docx
2023-11-CV-Automotive_131223.doc
2023-12-13-CV-MT-Ph-MR-BioT-Dev-TestRoles_131223.docx
2023-12-13-CV-MT-Ph-MR-BioT-Dev-TestRoles_131223.pdf
2023-12-18-CV-MT-Ph-MR-BioT-FocusSysReqEng-RiM-SomeQM-RA_191223.docx
2023-12-18-CV-MT-Ph-MR-BioT-FocusSysReqEng-RiM-SomeQM-RA_191223.pdf
2024-01-17-CV-MT-Ph-MR-BioT-LeadingRoles-RA-ALM-PLM_180124.docx
2024-01-17-CV-MT-Ph-MR-BioT-LeadingRoles-RA-ALM-PLM_180124.pdf
2024-01-12-CV-MT-Ph-MR-BioT-LeadingRoles-RA_180124.docx
2024-01-12-CV-MT-Ph-MR-BioT-LeadingRoles-RA_180124.pdf
2024-01-18-CV-MT-Ph-MR-BioT-BusinessAnalyst-RA-ALM-PLM_180124.docx
2024-01-18-CV-MT-Ph-MR-BioT-BusinessAnalyst-RA-ALM-PLM_180124.pdf
2023-11-CV-Automotive-FMEA_020224.docx
2023-11-CV-Automotive-FMEA_020224.pdf
2024-02-21-CV-MT-Ph-MR-BioT-QM-Auditor-RiM_290224.docx
2024-02-21-CV-MT-Ph-MR-BioT-QM-Auditor-RiM_290224.pdf
2024-02-27-CV-MT-MD-LS-fewPh-RiM-FMEAmod_290224.docx
2024-02-27-CV-MT-MD-LS-fewPh-RiM-FMEAmod_290224.pdf
2024-02-27-CV-MT-MD-LS-fNoBo_290224.docx
2024-02-27-CV-MT-MD-LS-fNoBo_290224.pdf
2024-02-27-CV-MT-Ph-MR-BioT-fNoBo-RA-Start-up_290224.docx
2024-02-27-CV-MT-Ph-MR-BioT-fNoBo-RA-Start-up_290224.pdf
2024-03-05-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester_260324.docx
2024-03-05-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester_260324.pdf
2024-03-11-CV-MT-Ph-MR-BioT-Leading-MES-LIMS_260324.docx
2024-03-11-CV-MT-Ph-MR-BioT-Leading-MES-LIMS_260324.pdf
2024-03-01-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM-AI-ScrumMaster_260324.docx
2024-03-01-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM-AI-ScrumMaster_260324.pdf
2024-01-CV-Automotive-FuSa-FMEA-Lead_260324.docx
2024-01-CV-Automotive-FuSa-FMEA-Lead_260324.pdf
2024-02-29-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM_260324.docx
2024-02-29-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM_260324.pdf
2024-03-01-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM-AI_260324.docx
2024-03-01-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-RiM-AI_260324.pdf
2024-03-11-CV-MT-Ph-MR-BioT-Leading-MES-LIMS_270324.docx
2024-03-11-CV-MT-Ph-MR-BioT-Leading-MES-LIMS_270324.pdf
2024-03-05-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-CSV_270324.docx
2024-03-05-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-CSV_270324.pdf
2024-03-27-CV-Allindustries-SiemOPC_270324.docx
2024-03-27-CV-Allindustries-SiemOPC_270324.pdf
2024-03-27-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-FocTesting_280324.docx
2024-03-27-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-FocTesting_280324.pdf
2024-03-27-CV-LifeSciences-MIX-SysEng-ReqEng-SW-HW-MD-FocMedTech_280324.docx
2024-03-27-CV-LifeSciences-MIX-SysEng-ReqEng-SW-HW-MD-FocMedTech_280324.pdf
2024-03-27-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-FocAIDev_280324.docx
2024-03-27-CV-LifeSciences-MIX-Sys-SW-HW-ReqEng-Leading-Scrum-SWDeveloper-Tester-FocAIDev_280324.pdf

Skills

Sergio Guillen
+49-17634975784,  sergio.guillen.engineering@gmail.com

Education:           
  • MSc - Master’s Degree (5-year worldwide accepted University program) in Engineering – 2 Specialties, 2002, UPV Valencia (Spain)

Professional Experience:           
  • More than 10 projects in MEDICAL TECHNOLOGIES, BIOTECH, PHARMA, MEDICAL DEVICES & Combination Products. Companies: ROCHE Diagnostics, SIEMENS Healthcare, MALLINCKRODT Pharmaceuticals, BioNTech SE, Haemonetics, B.Braun, Zimmer-Biomet, YPSOMED, ROCHE Diabetes Care, KARL STORZ SE, Mettler Toledo, FRAUNHOFER INSTITUTE, etc. More than 20 years of professional experience in international teams, mainly in Germany and Switzerland, but also in Ireland, USA, UK, Spain, France, Italy, Rumania, Austria, Hungary, and with different teams in Sweden, Mexico, Egypt, Israel, Australia and Asia (China, South Corea, India, Philippines and Japan).
  • Other final CLIENTS and EMPLOYERS in other BRANCHES: CERN (European Organization for Nuclear Research), BMW AG, Continental AG (3 projects), Fraunhofer Instititute IIS, Fraunhofer Institute IPMS, HELLA KGaA Hueck & Co, HL MANDO (HALLA Group), Delphi, LEAR Corporation, Kostal, Varroc Lighting, Marquardt. 
  • Several Audits: supplier Audits, internal Audits, mock-up Audits (ISO 13485, MDSAP, GCP, GMP, GAMP 5, GLP, GxP,  FDA 21 CFRs, FDA 21 CFR 211 / 820 / 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)
  • Additional KNOW HOW : Pharma, BioTech, Biomedicine & Biology – Cancer, Aging, Longevity, Omics –Genomics, Epigenomics, Proteomics, Transcriptomics, Metabolomics-, Lab-grown organs, etc (Research, Services, Products, Networking, etc.

Industries:
  • Medical Technologies / Pharma / Life Sciences / Medical Devices / Biotech / Technology applied Research on Life Sciences / Bioinformatics / Automotive

Roles:
  • SYSTEMS ENGINEER / PRODUCT LINE MANAGEMENT / VARIANT MANAGEMENT–PLM–ALM
  • REQUIREMENTS ENGINEER / REQUIREMENTS MANAGER (Customer & System & HW & SW Reqs)
  • System & HW & Software ARCHITECT / MedTech, Pharma and Biotech SENIOR ENGINEER
  • RISK MANAGEMENT (MedTech, Pharma, Biotech and Combination Products) / Functional Safety Engineer & Manager
  • TEAM LEAD / PROJECT MANAGER / PM / SAFe / Scrum Master / Scrum Product Owner
  • AI (Artificial Intelligence) / ML (Machine Learning) / Data Science / Algorithm Engineer
  • FMEA (also FMEDA) Issuer / Moderator
  • Software Development / Programming (Python, PyTorch, TensorFlow, Scikit-Learn, C++, C#, VBScript, Java, MATLAB, embedded C/C++, JavaScript, Delphi, SQL and PHP, Linux OS, VxWorks, Angular)

Other activities:
  • TESTING / Quality Assurance / Validation / CSV – Computer System Validation / Verification / Test Management
  • HW Development (ORCAD, EAGLE, ALTIUM) / Mechanical Design
  • QUALITY MANAGEMENT / LEAD AUDITOR / REGULATORY AFFAIRS / Documentation
  • REGULATORY AFFAIRS / REGISTRATION / APPROVAL / “ZULASSUNG”


Certifications/Trainings:
  • Certified Requirements ManagerIREB
  • INCOSE CSEP Systems Engineering Professional Certification Training
  • SAFe Trainings
  • SCRUM Trainings
  • BPMN (Business Process Model & Notation) & ADONIS BPM & ADOIT Suite Training, 2 days
  • Certified Risk Manager (TüV Nord)
  • FMEA moderator Training (4 days) - KVP Institut
  • Medical Devices LEAD AUDITOR Certification - bsi Group (Notified Body, British Standards Institution), 5 days, Frankfurt, Germany (ISO 19011:2018 / ISO 13485:2016)
  • MDSAP Auditor Training (Medical Device Single Audit Program) – bsi Group (Notified Body, British Standards Institution), 2 days
  • 3-day hands-on training about Safety Assurance Cases for Medical Devices - GessNet
  • Certified Auditor (ISO 13485:2016) – Johner Institut, Germany
  • MEDICAL TECHNOLOGIES, MEDICAL DEVICES, Biotech : AUDIT-GARANT (Advanced Professional Program for Medical Device Development and Clearance Process (Regulatory Affairs, Quality Mgmt, Technical Documentation and System Development: 47/EC, MDR, 510k, ISO 13485, ISO 14971, EN 62304, EN 62366, EN 60601-1-6, 21 CFR, HL7, DICOM, LOINC, GxP), Johner Institute
  • Different trainings on PHARMA & BioTech: GMP, GAMP5 Computer System Validation (CSV), User Requirements (URS) and Functional Specifications (FS) Definition, Risk Analysis&Management, Change Control, different DMSs (Document Management Systems), CAPAs and Action Management, ERPs and Supply Change Management and Warehouse Management Systems (SAP,GUS, etc)
  • IVDR Trainings
  • MDR (Medical Device Regulation) Implementation for CE-Marking – Training Course - bsi Group (Notified Body, British Standards Institution), 3 days, Frankfurt, Germany
  • Clinical Trials / Clinical Studies of Medical Products. 2 days training, June 2018, Bonn. FORUM Institut für Management
  • LIMS trainings
  • Several days of individual Training&Coaching in Project Management, Presentation, Interaction, Time Management and Rhetoric skills, techniques and tools
  • isQI CPMS (Certified Professional for Medical Software) – currently Exam preparation
  • iSQI ISTQB Certified Tester, currently Exam Preparation

Other:
  • 2018 (2days), 2nd Annual Drug/Device Combination Products Summit (Volanthen), Vienna
  • Additional extensive Further Training and Conference/Event Attendance in the Pharma, Biotech, Medicine and Medical Technology fields

Languages:           
  • Business level / Fluent in German, English and Italian
  • Mother tongues: Spanish and Valencian/Catalan
  • Basics: Russian, Swedish and French

Year of birth: 1977


PROFESSIONAL EXPERIENCE:

SYSTEMS ENGINEERING / VARIANT MANAGEMENT / requirements Engineering / SYSTEMS ARCHITECTURE / PLM / ALM / POLARION SERVER ADMINISTRATION / artificial intelligence, machine learning & DATA SCIence EngineerING / Consultant / RESPOSITORY MGMT / COACH / ADVISOR
  • 2023-2024, Germany&Remote
  • Project: AI Software Development (Artificial Intelligence/ Machine Learning / Deep Learning / Big-Data / Data Analysis / Data Science)
  • Activities & Tools: 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 / SAFe / SCRUM / 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 Administration / Scikit-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

REQUIREMENTS ENGINEER-MANAGER / SYSTEMS ENGINEER / Quality Management / COMPUTER System VALIDATION / GAMP 5 CSV / SOPs & WIs / PLANNING / BPMN / TEST MANAGEMENT / SOFTWARE / ERP / SUpply Chain Mgmt & Warehouse MGMT SYSTEMs
  • 2022-2023, Germany&Remote
  • End client: BioNTech SE (PHARMA)
  • Tools: 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 / SAFe / SCRUM / 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

RISK MANAGEMENT / fmea mODERATion & ISSUANCE / QUALITY MANAGEMENT / SYSTEMS ENGINEERING / team leading / Coordination / REQUIREMENTS ENGINEERING
  • 2022, Germany&Remote
  • RISK & QUALITY MANAGEMENT, Artificial Intelligence, Machine Vision & Sensor R&D
  • APIS IQ-RM Pro / DOORS / JIRA / SAFe / SCRUM / 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

SYSTEMS ENGINEER (+SW+HW+MD) / REQUIREMENTS MANAGER / SYSTEMS ARCHITECTURE / REGULATORY AFFAIRS / Risk Management / Variant Management- ALM- PLM CONSULTING
  • 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, SAFe / SCRUM / 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

SYSTEMS ENGINEER / REQUIREMENTS ENGINEER 7 REQUIREMENTS MANAGER / SYSTEMS ARCHITECTURE / 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)
  • 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 / requirements engineering / QUALITY MANAGEMENT / REGULATORY AFFAIRS
  • 2017-2018, Germany & Switzerland &Remote
  • End Clients: YPSOMED & ROCHE DIABES 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: Risk Manager / Quality Management / Systems Engineering / Regulatory Affairs / Registration Team / Post-market / Clinical Evaluation / Clinical Trials / Supplier Management / Safety Assurance Cases / Requirements Engineering
  • 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 / SAFe / SCRUM  / 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 ENGINEER / REQUIREMENTS MANAGER / 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, SAFe / SCRUM, 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

TECHNICAL PROJECT MANAGER / SYSTEMS LEAD / requeriments Management / Requirements ENgineering / RISK MANAGEMENET / FUNCTIONAL SAFETY ManageMENT-ENGINEERING
  • 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, SAFe / SCRUM, 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 ENGINEER / REQUIREMENTS ENGINEERING / REGULATORY AFFAIRS / QUALITY MANAGEMENT / AUDITS / SYSTEM ARCHITECTURE
  • 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)

REQUIREMENTS ENGINEER-MANAGER  / SYSTEMS ENGINEERING / SYSTEM ARCHITECTURE / SCRUM MASTER / TESTING / RISK MANAGEMENT / QUALITY CONTROL / DEVELOPMENT ENGINEER / QUALITY 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 more than 60 people. Multi-cultural and multi-location team (6 locations in different countries).
  • Audits, 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

REQUIREMENTS ENGINEER / SOFTWARE DEVELOPER / TESTER / SW ARCHITECTURE&DESIGN
  • 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

SYSTEMS ENGINEER / 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

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.  


SKILLS & TECHNOLOGIES:
 
  • Applied and theoretical knowledge of PHARMA / MEDICAL TECHNOLOGIES / BioTech Specifications and Laws/Regulations: Design, Quality, Regulatory Affairs, GxP, GMP, GCP, GLP, GAMP 5, CSV, FDA 21 CFRs, FDA 21 CFR 58, Digitalization, Toolchain/ALM/PLM coaching, process documentation, Patient Data Protection, HIPAA (Health and Accountability Act), Cyber-Security, 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 / LLMs (Large Language Models) / Cybersecurity / Data Lakehouses / Neural Networks / Deep Learning / generative AI / 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).

Tools:
 
  • RISK MANAGEMENT, FUNCTIONAL SAFETY and QUALITY MANAGEMENT: GessNet Turbo-AC, 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 tool-chain, 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.


SCIENTIFICAL ACTIVITIES
•            Main Author of 5 scientific papers (and Co-Author of an additional one) published in high reputed scientific magazines and conference proceedings.
•            Speaker in 2 scientific international conferences: ICCE’09 (IEEE International Conference on Consumer Electronics - ICCE, Las Vegas, USA, January 2009) and ICCE’08.

ATTENDED FURTHER TRAINING, CONFERENCES and EXHIBITONS
PHARMA / MEDICINE / MEDICAL TECHNOLOGIES
  • GAMP5 Computer System Validation (CSV) (Pharma, Biotech)
  • User Requirements (URS) Definition (Pharma, Biotech, MedTech)
  • GMP Trainings
  • Risk Analysis Execution (Pharma, MedTech)
  • Change Control (Pharma, MedTech)
  • Trainings of different DMSs (Document Management Systems) (Pharma, MedTech)
  • CAPA and Action Management
  • Trainings on ERPs and Suppy Change Management and Warehouse Management Systems (SAP,GUS, etc)
  • isQI CPMS (Certified Professional for Medical Software) - Exam preparation on-going
  • Advanced Professional Program for Medical Device Development and Clearance (47/EC, MDR, 510k, ISO 13485, ISO 14971, EN 62304, EN 62366, EN 60601-1-6, 21 CFR, HL7, DICOM, LOINC), Johner Institute (on-going)
  • Intern Auditor / Assessor for Medical Devices (ISO 13485 / ISO 9001), Johner Institute (on-going)
  • Additional extensive Further Training and Conference/Event Attendance in the Medicine (especially in the Human Aging / Lifespan Increase fields) and Medical Technologies fields
  • CAPA Training, 2016.
  • Training on “Polymerase Chain Reaction (PCR) process for in-vitro diagnosis”, 2013.
  • Different Trainings on HL7, Documentation, SYS/SW/HW Architecture, Requirements Engineering, SW Development, Agile Development and Scrum for Medical Technologies, 2013.
  • “The molecular Mechanisms of Aging”, 2015 (6 weeks part-time Seminar)
  • Several Trade Fairs attended: MedConf @ Munich, MEDICA @ Dusseldorf, Biotechnica @ Hannover, etc.
  • Conferences:
    • MedConf. 2009 & 2012, Munich (Germany).
    • European Association Pharma Biotechnology (EAPB) conference – Science to Market, 2009.
    • 2nd Biomanufacturing Symposium. 2009, Hannover (Germany).
    • Congress on Controversies in Longevity, Health and Aging. 2010, Barcelona (Spain).
    • PEGSummit Europe - Protein & Antibody Engineering Summit. 2010, Hannover (Germany).
    • Aging Institute Conference. 2010, Brussels (Belgium).



FUNCTIONAL SAFETY / SAFETY CRITICAL SYSTEMS / MEDICAL TECHNOLOGIES
  • Certified Automotive Functional Safety Professional (AFSP) - ISO 26262 Certification (TüV Saar, Germany), 2015. Including 5-days full training.
  • Safetronic Conference (ISO 26262). Carl Hanser Verlag GmbH, November 2015, Stuttgart (2 days).
  • SW Tool Medini Analyze (KPIT/ikv) for IEC 61508, IEC 62304 and ISO 26262. 2015, Cologne (2 days).
  • TüV Saar ISO 26262 Certification Training and AFSP certification. September 2015, Cologne (5 days).
  • 7th International Annual Conference ISO 26262 – Euroforum. September 2015, Stuttgart (3 days).
  • “Functional Safety (ISO 26262) in the Automotive Branch, for System Engineers”. 2012 (3 full-days).
  • Fairs MedConf 2009 & 2012 in Munich & Biotechnica 2009 in Hannover, both in Germany (I attended to a lot of workshops and speeches about norms, development process details & process of market approval & authorization of Medical Devices)
  • “Software Requirements in Medical Technologies with Borland Caliber”
  • “Risk Managament for Medical Software Development (IEC 62304, ISO 14971, IEC 80002)”
  • “IEC 61508 – Developing Safety-oriented Software”
  • “Safety Critical Systems Design with UML”
  • “C++ for Safety-Critical Systems” / “Design of Safety-Critical Systems”
                                                                                              
PROJECT MANAGEMENT / TEAM LEADING / PRESENTATIONS SKILLS / TIME MANAGEMENT / BUSINESS MANAGEMENT SKILLS:
  • PMP - PMI Certification Exam Preparation (on-going)
  • IREB Certified Professional for REQUIREMENTS ENGINEERING, 2010
  • Several days of individual Training&Coaching in Project Management, Presentation, Interaction, Time Management and Rhetoric skills, techniques and tools
  • Abundance 360 Program and Summit on Exponential Technologies by the Singularity University, 1-year program, by Peter Diamandis
  • Xponential Advantage Program of the SUCCESS ACADEMY, 1-year program, by Tony Robbins and Peter Diamandis
  • Software Project Management / Software Team Leading / Project Management / Management of Engineering Projects
  • Documentation Management with SAP / SCRUM

Application and Product Lifecycle (ALM, PLM), REQUIREMENTS, ARCHITECTURE, CM, VM, DESIGN, PROGRAMMING & TESTING
  • “Advanced IBM Rhapsody” Training, 1 full day, 2014, Regensburg (Germany)
  • “Configuration Management with Serena Dimensions CM”
  • Conference REConf’11 on Requirements Engineering (with a lot of workshops and speeches about Requirements Engineering)
  • “Requirements Engineering and Management for product lines and variants”
  • “Advanced Requirements Specification  Modeling and Diagrams”
  • “Advanced Elicitation and Specification of Non Functional Requirements”
  • “Requirements-based Testing”
  • “Preparation for the CSEP Systems Engineering Professional Certification of the INCOSE”
  • “Requirements Management & Engineering – IREB Certified Professional for Requirements Engineering” + certification exam / Conference REConf’10 on Requirements Engineering (with a lot of workshops and speeches about Requirements Engineering)
  • “Requirements Engineering & Process Reference Models (SPICE, CMMI, IEC 15504 & 12207)”
  • “CPP Unit Testing” / “Embedded Linux”
  • “Praxis Workshop: developing successfully with ARM”
  • “Setting-up an automotive Multimedia Target”
  • “Life Cycle in Development of Automotive Multimedia Devices (for Software Architects and Developers)”
  • “Telelogic CM Synergy” / “Telelogic Rhapsody – SW Architecture and Code Generation”, 2011
  • “From C to C++: Writing reliable C/C++ code, C to C++ Migration for Embedded Systems, C++ for Embedded Applications”
  • “Architectural design of device drivers”/ “ARM embedded software”/ “Programming videogames”

MODELING & SIMULATION
  • BPMN (Business Process Model & Notation) & ADONIS BPM & ADOIT Suite Training, 2 days
  • “Model-Based Development with Eclipse (Hands-on)”
  • “Modeling Embedded Systems with UML”
  • “Telelogic Rhapsody, UML and AUTOSAR for automotive applications”
  • “HW Modelling with SystemC”

GRAPHICS/ AUDIO-VIDEO/ MULTIMEDIA
  •  “Human Interface Design”
  • “The 3D Graphics Pipeline from an OpenGL ES Perspective”
  • “Architecture Trade-Offs for Embedded Audio/Video”
  • “Multimedia systems”

HARDWARE DEVELOPMENT
  • “Xilinx TechClass”
  • “Design of high speed digital systems”
  • “Design and Synthesis of Complex Digital Systems”
  • “Microprocessors XX86 and the PC architecture”
  • “Modelling and verification of complex digital systems”
  • “Multiprocessor digital systems”
  • “HW Modelling with SystemC”
  • “Microcontrollers and advanced buses”

ELECTRONICS
  • “New Technologies for data acquisition applications”
  • “Measurement techniques, signal analysis and report generation”
  • “Technological development of new materials”

PHYSICS: “Special Relativity”/ “History of Physics”
IT/TELEMATICS/NETWORKS: “Corporative networks”/“Linux administration”/“Bridging local networks to optical backbones”
QUALITY MANAGEMENT: “Quality control and reliability”/ “Quality management and control” 
DOCUMENTATION: “Authoring professional reports”/ “Document authoring with LaTeX Document Preparation System”
OTHER: “Workshop on Insurances, Tax and Contract Law for Subcontracts in the IT-Sector” / “Workshop on Stock Trading with derivatives and structured products” / “Learning techniques”/ “Professional Typing”

Projekthistorie

11/2020 - 03/2024
Systems Engineer / Risk Manager / Team Lead / FMEA Moderator / SW&HW Engineering
MALLINCKRODT Pharmaceuticals (Pharma und Medizintechnik, >10.000 Mitarbeiter)

SYSTEMS ENGINEERING LEAD (Additional tasks: regulatory affairs / quality&risk management) & ALM/PLM CONSULTANT
  • 2020 till End 2021, Republic or Ireland
  • End client: MALLINCKRODT Pharmaceuticals
  • 2 projects: Nitric Oxide pulmonary Delivery System (China registration) & Extracorporeal blood Photophoresis / Photopheresis System (ECP)
  • SOFTWARE & HARDWARE, Introduction of Software tools in the company, Project Planning, 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. V-Model, Microsoft Project, Enterprise Architect/EA/SysML/UML, JAMA ReqEng, listing of international standards, resource planning, budgeting, regulations and guidelines applicable to the project (including the conversion of clauses into design input requirements), gap analysis. Phases: 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

06/2001 - 11/2020
Systems Engineer / Risk Manager / Auditor / Team Lead / Project Manager / Quality Manager / ALM-PLM Consultant / Requeriments Engineer / FMEA / SW Developer / V&V Tester
Different companies ( MedTech, Pharma, Bitoech, Automotive) : Haemonetics, B.Braun, Zimmer Biomet, Ypsomed, SIEMENS Healthcare, ROCHE, Karl Storz, Mettler Toledo, Fraunhofer Institute, etc. (Pharma und Medizintechnik, >10.000 Mitarbeiter)

SYSTEMS ENGINEERING LEAD (additional tasks: risk engineering-management / requirements management/engineering)

  • 2020, Germany

  • End client: KARL STORZ SE & Co.KG

  • Project: Development and Clearance of a fully integrated Operating Theater for an Operating/Surgery Hospital Room  

  • MEDICAL TECHNOLOGIES

  • Function: ALM-PLM Consultancy&Planning&Implementation, Systems Engineering Leading / Risk Management Engineering / Regulatoy Affairs Support / DMS / Clearance Support.

  • IEC 60601, MDD/IVD, MDR/IVDR, SaMD (Software as a Medical Device), ISO 14971, AAMI TIR32, AAMI TIR57, 21 CFR 820, ISO 13485, IEC 6230. SysML, V-Model, SCRUM, Agile

 

 

QUAlity Management (LEAD AUDITOR: MEDICAL DEVICES, MEDICAL TECHNOLOGIES)

  • 2019-2020: Switzerland, France, Hungary and UK + Germany.

  • End Client: HAEMONETICS

  • 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)

  • ISO 13485:2016, SaMD (Software as a Medical Device), MDSAP, 21 CFR/FDA, ISO 9001, MDD/IVD, MDR/IVDR, ISO 14971, EN 62304, EN 62366, CSV, GMP, GCP, GLP, GAMP, MES, LIMS. V-Model, SCRUM, Agile

 

ENGINEERING LEAD / RISK MANAGEMENT (additional tasks: safety assurance cases leading / requirements engineering / regulatory affairs / quality engineering )

  • 2017-2018, Germany & Switzerland

  • End Clients: YPSOMED

  • 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 / Supplier Management / Safety Assurance Cases / Quality Engineer / Requirements Engineer

  • Main Task/Goal: Engineering Lead / 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 -, SIEMENS MES, SIEMENS Opcenter, DMS, Labware LIMS, Preliminary Hazard Lists and Analysis, Risk Analysis, FTAs and FMEAs; DHF, DMR & DHR; SACs: in the case of insulin pumps, based 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

  • SOFTWARE & HARDWARE, Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / V-Model, Agile, Scrum, UML, SysML / LIMS, MES

  • Polarion, DOORS, Turbo-AC, etc.

  • Additional Tasks: 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).

 

SYSTEMS ENGINEERING LEAD (additional tasks: SW quality & design engineer / requirements management / regulatory affairs)

  • 2016-2017, France

  • End Client: ZIMMER BIOMET

  • Project: Development & DHF (Design History File) Remediation Activities: minimal-invasive chirurgical electro-mechanical device (robot) - innovative high-precision deep brain & spine SURGERY ROBOT. Audits, Gap Analysis, Gap Assessment and Gap Closing Planning and Execution.

  • MEDICAL TECHNOLOGIES (Class 2b device)

  • Function: Systems Engineering / Requirements Management / ALM-PLM Consultancy&Planning&Implementation / Regulatory Affairs Support / DMS / Clearance Support / RIMS / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / MES

  • SOFTWARE & HARDWARE, Introduction of Software tools in the company, Polarion, Supplier Management, 93/42/EEC, 2007/47/EC, CSV, Cybersecurity, MDD, 510k submission, EN ISO 13485(Quality Management), EN ISO 14971 (Risk Mgmtt), EN 62304 (Software Lifecycle), Usability (EN 62366 & EN 60601-1-6), FDA 21 CFR parts 820, 803&806. / Test Case Derivation, Development, CAPAs, Execution&Reporting / DHF, DMR & DHR, Audits / V-Model / Agile / SCRUM / SysML / WiFi

 

 

PROJECT MANAGEMENT / ENGINEERING LEAD (additional tasks: functional safety manager-engineer / risk manager / team lead / requirements management)

  • 2014-2016, GERMANY.

  • SAFETY CRITICAL SYSTEMS.

  • Tools: Medini Analyze, APIS IQ, PTC Integrity and ReqEng, Subversion, MS Project, IBM DOORS, Enterprise Architect, MS Visio, Power Point, Excel. Among others: Battery Management, ADAS, Radar, Camera Systems, Laser scanner, Laser / LED lights.

  • ALM-PLM Consultancy&Planning&Implementation, Presentations, coaching of development; checklists, templates and process definition.

  • FMEA (and DFMEA/FMEDA) Issuing and Moderation, Cyber-Security, Audits.

  • Coordination of external partners and internal teams, Introduction of Software tools in the company, Resource planning, project planning, budgeting / Responsible, author, coordinator, reviewer and/or co-author of different work products or responsible for Systems Engineering / Risk Management / Functional Safety Lifecycle: Hazard & Risk Analysis, Safety Concepts, FuSa effort estimation, customer/partner/supplier interface (DIA), Supplier Management, Safety Plan, Impact Analysis, FMEA, DFMEA/FMEDA, FuSa Test Specs, Safety Case, FuSa Assessments. Audits, Gap Analysis, Gap Assessment and Gap Closing Planning and Execution. V-Model / Agile / SCRUM, China & Russia registrations

 

PROJECT MANAGEMENT / QUALITY & DEVELOPMENT ENGINEER / REGULATORY AFFAIRS

  • 2013-2014.

  • End Client: B. BRAUN

  • Project: DHF Remediation activities / Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / FDA-clearance 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

  • 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

 

SYSTEM & SW & HW ENGINEER / REQUIREMENTS ENGINEER / DEVELOPMENT ENGINEER

  • 2012-2013.

  • Project: PCR Diagnostics Device / New Development of the to date highest throughput medical in-vitro diagnosis (IVD) for different diseases (HIV, Hepatitis, etc.) based on PCR technology.

  • MEDICAL TECHNOLOGIES – Polarion, HP-QC, ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / CSV / RIMS / EU & FDA clearance-approval process / Cyber-Security / WiFi / SIEMENS MES, SIEMENS Opcenter / DMS / FDA 21 CFR 820 / MES. CAPAs / LIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / FDA 21 CFR 803 & 806. / Test Case Derivation, Development, Execution and Reporting

  • Function: Systems Engineer / HW & SW Development / Requirements Engineer / Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management / V-Model /Agile / Scrum / SysML / UML

 

TECHNICAL PROJECT MANAGER (Engineering Product Leader - EPL), FUNCIONAL SAFETY PROJECT LEAD and TEAM LEADER OF THE FUNCTIONAL SAFETY SW-DEVELOPMENT TEAM

  • 2011-2012, Baden-Württemberg, GERMANY.

  • 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, WiFi , Cybersecurity. V-Model

  • Project Planning / Introduction of Software tools in the company / Coordination of external partners and internal teams / Resource Planning / Budgeting / MS Project. 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).

 

QUALITY ASSURANCE TEAM LEAD / ASSESSMENT PREPARATION

  • 2011, GERMANY.

  • MS Project, MS Power Point, IBM/Telelogic Rational DOORS

  • Multi-site (& multi-country) Team Leading. Coordination of external partners and internal teams, Gap Analysis, Gap Assessment and Gap Closing Planning and Execution. Goal of the Project: Process Improvement of a multi-site development as preparation for an Assessment. Disciplines: ALM/PLM Consultancy&Planning&Implementation , Introduction of Software tools in the company, 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, Audits, Cyber-Security, V-Model.

 

REQUIREMENTS MANAGER & SOFTWARE ARCHITECT

  • 2010-2011, GERMANY .

  • SAFETY CRITICAL SYSTEMS.

  • Requirements Engineering / Test Case Derivation, Development, Execution and Reporting

 

REQUIREMENTS MANAGER -HP QUALITY CENTER- AND SYSTEMS & SW ARCHITECT

  • 2010-2011, SWITZERLAND.

  • End Client: METTLER-TOLEDO

  • Project: Precision electronic system for liquid-powder mixing to be used in the Pharma Industry and Medical Research / 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: 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

  • 2009-2010, GERMANY.

  • End Client: SIEMENS HEALTHCARE

  • Project: Development of a medical in-vitro diagnosis (IVD) of blood coagulation through optical technology.

  • MEDICAL TECHNOLOGIES / SAFETY CRITICAL SYSTEMS / CSV / PRECISSION MEASUREMENT ELECTRONICS / LED / Optics / OPTICAL TECHNOLOGIES / LABDATA LIMS / Test Case Derivation / Cybersecurity / WiFi / Wireless USB / MATLAB / C, C++ / ALTIUM / SIEMENS MES, SIEMENS Opcenter / V-Model / Agile / 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.

 

TEAM LEAD / SYSTEMS ENGINEER / SW ARCHITECT / SW DEVELOPER / HW DEVELOPER / Testing

  • 2004-2008, GERMANY.

  • Company: FRAUNHOFER INSTITUTE IPMS (Dresden)

  • MEDICAL TECHNOLOGIES / PHARMA . Video Camera for Medical Applications / Optics / GxP

  • Team Leading / Software and Hardware Architecture, Development and Testing / ORCAD, WiFi, C, C++, MATLAB, Java

  • Company: Fraunhofer Institute IPMS, GERMANY.

 

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. ROLE: Hardware Designer & Developer –VHDL-

  • 2002-2003. Software Developer and Tester 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++ / Delphi / MATLAB / ALM-PLM Planning&Implementation

  • 2001-2002. Fields: Laser / OPTICS RESEARCH / MODELLING & SIMULATION.

Zertifikate

Certified Lead Auditor ISO 13485
BSI Training Academy
2019
MDSAP - Medical Device Single Audit Program Readiness
BSI Training Academy
2019
Certified Risk Manager
TüV Saar
2015
Certified Requirements Engineer
IREB
2010

Reisebereitschaft

Weltweit verfügbar
Available for projects worldwide. But ideally in or close to Valencia (Spain) or Frankfurt (Germany).

exali IT-Haftpflicht-Siegel (Sondertarif für Freelancermap-Mitglieder)

Das original exali IT-Haftpflicht-Siegel bestätigt dem Auftraggeber, dass die betreffende Person oder Firma eine aktuell gültige branchenspezifische Berufs- bzw. Betriebshaftpflichtversicherung abgeschlossen hat. Diese Versicherung wurde zum Sondertarif für Freelancermap-Mitglieder abgeschlossen.

Versicherungsbeginn:
02.02.2011

Versicherungsende:
01.03.2026

Profilbild von Anonymes Profil, MedTech/Pharma/Biotech Risk&QM&Reqs Mgr-Engineer/Team-Project Lead / SYS & SW & HW Architect MedTech/Pharma/Biotech Risk&QM&Reqs Mgr-Engineer/Team-Project Lead / SYS & SW & HW Architect
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