Systems Engineer
Mallinckrodt Pharmaceuticals
(Pharmaceuticals and medical technology, >10.000 employees)
Keywords
Programming
Usability Engineer
Scrum Master
EN 60601-1-6
Requirements Engineering
ASPICE
medical technologies
certified requirements engineer
Scrum
Automotives
ISO 13485
DICOM
47/EC
510k
Automotive
EN 60601
scrum product owner
Embedded
26262
ISO 26262
LOINC
ISO 14971
Usability
ISO 13845
C
MDR
Functional Safety
HL7
FuSi
Team lead
Medical Engineering
ISO 62366
IREB Requirements Engineer
IEC 61508
EN62304
EN 62304
21 CFR
Risk Management Solutions
EN 62366
Skills
Sergio Guillen, +49-17634975784, sergio.guillen.engineering@gmail.com
Education
PROFESSIONAL EXPERIENCE:
PHARMA / COMPUTER System VALIDATION / GAMP 5 CSV / SOPs & WIs / PLANNING / BPMN / TEST MANAGEMENT / Quality Management / REQUIREMENTS ENGINEERING
• 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
PROJECT MANAGEMENT / TEAM LEADING / PRESENTATIONS SKILLS / TIME MANAGEMENT / BUSINESS MANAGEMENT SKILLS:
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”
Education
- Master’s Degree (5-year worldwide accepted University program) in Telecommunications Engineering – Specialties Electronics & Telecommunications, 2002, UPV (Valencia,Spain)
- More than 10 projects in PHARMA, MEDICAL TECHNOLOGIES, BIOTECH & Combination Products. Companies: BioNTech SE, MALLINCKRODT Pharmaceuticals, Haemonetics, ROCHE Diagnostics, B.Braun, Zimmer-Biomet, YPSOMED, ROCHE Diabetes Care, SIEMENS Healthcare, 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).
- Additional Know-How in Pharma, Biomedicine & Biology – Cancer, Aging, Longevity, Omics –Genomics, Epigenomics, Proteomics, Transcriptomics, Metabolomics-, Lab-grown organs, etc (Research, Services, Products, Promotion, etc)
- Several Audits: supplier Audits, internal Audits, mock-up Audits (ISO 13485, MDSAP, GCP, GMP, GAMP 5, GLP, GxP, FDA 21 CFRs, FDA 21 CFR 58, ISO 9001, ISO 14971, EN 62304, EN 62366, EN 60601, EU/MDD/MDR/IVDD/IVDR, USA/FDA, Canada/HC, Australia/TGA, Brasil/ANVISA, Japan/MHLW, etc)
- Pharma / Medical Technologies / Life Sciences / Medical Devices / Biotech / Technology applied to Bio-Research / Bioinformatics
- SYSTEMS ENGINEER / REQUIREMENTS MANAGER (Customer & System & HW & SW Reqs) / System & HW & SW ARCHITECT / MedTech, Pharma and Biotech SENIOR ENGINEER
- TEAM LEAD / PROJECT MANAGER / PM / Scrum Master / Scrum Product Owner
- RISK MANAGER (MedTech, Pharma, Biotech and Combination Products) / Functional Safety Engineer & Manager
- LEAD AUDITOR / QUALITY MANAGEMENT / Regulatory Affairs
- TESTING / Quality Assurance / Validation / CSV – Computer System Validation / Verification / Test Management
- FMEA (also FMEDA) Issuer / Moderator
- SW Programming (C++, C#, VBScript, Java, MATLAB, Python, embedded C/C++, JavaScript, Delphi, SQL and PHP, Linux OS, VxWorks, Angular)
- HW Development (ORCAD, EAGLE, ALTIUM) / Mechanical Design
- Different trainings on 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)
- AUDIT-GARANT (Medical Devices, Medical Technologies) : 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
- Medical Devices and Pharma LEAD AUDITOR Certification - bsi Group (Notified Body, British Standards Institution), 5 days, Frankfurt, Germany (ISO 19011:2018 / ISO 13485:2016)
- Certified Requirements Manager – IREB
- LIMS trainings
- BPMN (Business Process Model & Notation) & ADONIS BPM & ADOIT Suite Training, 2 days
- MDSAP Auditor Training (Medical Device Single Audit Program) – bsi Group (Notified Body, British Standards Institution), 2 days
- MDR (Medical Device Regulation) Implementation for CE-Marking – Training Course - bsi Group (Notified Body, British Standards Institution), 3 days, Frankfurt, Germany
- FMEA moderator Training - KVP Institut
- 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
- Clinical Trials / Clinical Studies of Medical Products. 2 days training, June 2018, Bonn. FORUM Institut für Management
- 3-day hands-on training about Safety Assurance Cases for Medical Devices - GessNet
- Certified Risk Manager (TüV Nord)
- Certified Auditor (ISO 13485:2016) – Johner Institut, Germany
- 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
- Business level / Fluent in German, English and Italian
- Mother tongues: Spanish and Valencian/Catalan
- Basics: Russian, Swedish and French
PROFESSIONAL EXPERIENCE:
PHARMA / COMPUTER System VALIDATION / GAMP 5 CSV / SOPs & WIs / PLANNING / BPMN / TEST MANAGEMENT / Quality Management / REQUIREMENTS ENGINEERING
- 20222023, Germany&Remote
- End client: BioNTech SE (PHARMA)
- Tools: MS Office / Adonis BPM / GUSOS ERP / SAP ERP / SOP-Guard /Alpega TMS / MS Navision / WinSped / MS Teams – Sharepoint / LabWare LIMS & ELN / MES
- Activities: 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) / SAP Cutover Planning and Execution / 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 / 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 / Audit Trials / Changes / Databases / SQL / CAPAs / V-Model & SCRUM
- 2022, Germany&Remote
- RISK & QUALITY MANAGEMENT
- APIS IQRM Pro / DOORS / JIRA / Medini Analyze / PTC-MKS Integrity / Enterprise Architect
- FMEA Issuance and Moderation (SYS/SW/HW/MD) / Team Leading / Coordination / Systems Engineering / Risk Management / Requirements Engineering / Quality Management / Documentation / CoachingTraining / Safety Related Hardware, Mechanical Design, Software and System Level FMEAs / FTAs / Safety Analysis / C-C++ / VB.NET
- 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 Photophoresis / Photopheresis System (ECP)
- Systems Engineering, Regulatory Affairs, Risk Management, Quality Management Quality Management, 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, VModel, 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, Python, JAVA, JavaScript
- 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: ALMPLM 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 )
- KnowHow: 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, VModel, Scrum, Agile
- 20192020: 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, mockup 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,
- 20172018, 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 / Autoinjectors & Pens / SaMD (Software as a Medical Device)
- MEDICAL TECHNOLOGIES (Class 2 device) and PHARMA (Combination Products)
- Function: Regulatory Affairs Support / Clearance Support / Postmarket / Clinical Evaluation / Clinical Trials / Risk Manager / Supplier Management / Safety Assurance Cases / Quality Engineer / Requirements Engineer
- Main Tasks/Goals: Engineering Lead / Resource planning / Introduction of Software tools in the company / Coordination of external partners and internal teams / Budgeting / Risk Management / ALMPLM 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
- 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).
- Tools / Skills: Java, JavaScript, Python, Angular & Testing tools / VModel, Agile, Scrum, UML, SysML / LabWare LIMS & ELN, MES SAP, Siemens Polarion & Teamcenter ( ALM – PLM ), Google Cloud / Databases / SQL, Polarion, DOORS, Turbo-AC, SaMD (Software as a medical device), GLP, GxP, Papers on cybersecurity, transition MDD/IVD to MDR/IVDR, GAMP5, Computer System Validation (CSV)
- Project: Audit & Development & DHF (Design History File) Remediation Activities: minimalinvasive chirurgical electro-mechanical device (robot) - innovative high-precision brain & spine SURGERY.
- End Client: ZIMMER BIOMET (MedTech)
- MEDICAL TECHNOLOGIES (Class 2b device)
- 20162017.
- SaMD (Software as a medical device), 93/42/EEC, 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), 510k submission, / Regulatory Affairs / Project Management / DMS / Clearance Support / Systems Engineering / Risk Management / RIMs / Quality Engineering / Testing / Postmarket / Clinical Evaluation / Clinical Trials / EN ISO 13485(Quality Management), EN ISO 14971 (Risk Management), EN 62304 (Software Lifecycle), Usability (EN 62366 & EN 60601-1-6), FDA 21 CFR parts 820, 803 and 806.
- 20142016, 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.
- Audits, Presentations, coaching of development; checklists, templates and process definition.
- FMEA (and FMEDA) Issuing&Moderation, Java, Javascript, Labview, C#, Matlab Simulink, C++
- Depending on the project, responsible, author, coordinator, reviewer and/or coauthour 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.
- 20132014.
- End Client: B. BRAUN (PHARMA & MedTech & Combination Products)
- Project: Audits / DHF Remediation activities / Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / FDAclearance 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 clearanceapproval 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)
- Function: Requirements Engineering / Regulatory Affairs Support / Clearance Support / Postmarket / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management / V-Model / Agile / SCRUM / SysML
- 20122013.
- End Client: ROCHE Diagnostics (MedTech & PHARMA)
- Project: New Development of the to date highest throughput medical invitro 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 / 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.
- 20112012, 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 HWTeam, 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, Functional Safety (ISO 26262) project leader (HW+SW) & Team Leader/Functional Owner of the FuSiSW-Development team (ca. 8 people). Multi-location / remote team (4 locations) / C, C++, VxWorks OS, DSP, CppUTest
- 2011, GERMANY&Remote
- Audits, MS Project, MS Power Point, IBM/Telelogic Rational DOORS
- Multisite (& multicountry) 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
- 20102011, Northern Region, GERMANY&Remote
- SAFETY CRITICAL SYSTEMS.
- Videoprocessing, DSP, OpenGL, Adobe Video libraries, C, C++, Qt, Microsoft Windows RT OS, Perl , PerlUnit, Test::Unit, Python, UnitTest++, QtTest
- 20102011, SWITZERLAND.
- End Client: METTLERTOLEDO (MedTech)
- Project: Precision electronic system for liquidpowder 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: Audits / Requirements Engineering / Regulatoy Affairs Support / Clearance Support / Postmarket / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management
- 20092010, GERMANY.
- End Client: SIEMENS HEALTHCARE (MedTech)
- Project: Development of a medical invitro 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
- 2008, Independent Agent.
- IMPORTEXPORT 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.
- 20042008, GERMANY.
- Company: FRAUNHOFER INSTITUTE IPMS (Dresden)
- Communications Technology & VideoTechnology & MEDICAL TECHNOLOGIES, Verilog, SVUnit, Vunit, C, C++, MATLAB, Unit++, Matlab xUnit, matlab.unittest
- 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, 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. Fields: OPTICS RESEARCH / MODELLING & SIMULATION.
- Applied and theoretical knowledge of PHARMA / MEDICAL TECHNOLOGIES / BioTech Specifications and Laws/Regulations: Design, Quality, Regulatory Affairs, GxP, GMP, GCP, GLP, GAMP 5, CSV (Computer System Validation), FDA 21 CFRs, FDA 21 CFR 58, Digitalization, Toolchain/ALM/PLM coaching, process documentation, 93/42/EEC, 2007/47/EC, 2016/MDR (Medical Device Regulation), 510k submission, EN ISO 13485(Quality Management), EN ISO 14971 (Risk Management), EN 62304 (Software Lifecycle), Usability (EN 62366 & EN 60601-1-6), LIMS, FDA 21 CFR part 820. Other: DICOM, LOINC, HL7, FDA 21 CFR 803, FDA 21 CFR 806, MES, ISO/IEC 15026-2, ISO 9001, ISO 9003, GxP / GEP / GMP / GAMP / GCP / GCP / GCLP / GDP, EN 60601, IEC 12207, IEC 61508, ISO 61010, GAMP-CSV.
- 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.
- RISK MANAGEMENT & FUNCTIONAL SAFETY & Critical System Design & Development in the Medical Technologies and in the 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.
- QUALITY MANAGEMENT / PROCESS: 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.
- PROGRAMMING, MODELING, SIMULATION, SYS&SW&HW DESIGN/ARCHITECTURE: SysML, UML Modeling, OOA, OOD, OOP (Object Oriented Architecture, Design & Programming) / AUTOSAR 4 / Model-driven Development / Automatic Code Generation / Architecture & Design Patterns / Reverse Engineering. C++, C#, VBScript, Java, LabView, MATLAB, Simulink, Python, C/C++, Delphi, SQL and PHP
- 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.
- 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.
- 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).
- 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
- 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.
- PHARMA / Biotech / Medical / LAB tools : Minitab, STARLIMS & LabWare LIMS & ELN, MES (for MedTech/Pharma/BioLabs)
- 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
- SOFTWARE DEVELOPMENT ENVIRONMENTS, Programming Languages, Integration and DEBUG&DIAGNOSE TOOLS: Google Cloud / Databases / SQL, C++, C#, Python, embedded C/C++, Java and PHP; GIT, MAVEN, Jenkins, Project experience with Eclipse, Xilinx SDK, MS Visual Studio, Tableau, Freescale CodeWarrior, TI Code Composer Studio, IAR Embedded Workbench, Looker, ARM RealView Dev Suite. TUX UTest, Tessy, IBM Rational Test Real Time (RTRT)... Vector/CAN Tools: CANopen, CANoe, CANape & CANKing. Tcl/Tk, D’Oxygen
- 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, 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.
- GRAPHICAL PROGRAMMING: Open GL (ES) API, NVidia GPUs and Adobe Flash Lite.
• 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).
- etc
- 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”
- “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”
- 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”
- “Human Interface Design”
- “The 3D Graphics Pipeline from an OpenGL ES Perspective”
- “Architecture Trade-Offs for Embedded Audio/Video”
- “Multimedia systems”
- “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”
- “New Technologies for data acquisition applications”
- “Measurement techniques, signal analysis and report generation”
- “Technological development of new materials”
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”
Project history
11/2020
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12/2021
SYSTEMS ENGINEERING LEAD (Additional tasks: regulatory affairs / quality&risk management) & ALM/PLM CONSULTANT
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2020 till End 2021, Republic or Ireland
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End client: MALLINCKRODT Pharmaceuticals
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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.
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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
adsfadf
(Pharmaceuticals and medical technology, >10.000 employees)
SYSTEMS ENGINEERING LEAD (additional tasks: risk engineering-management / requirements management/engineering)
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2020, Germany
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End client: KARL STORZ SE & Co.KG
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Project: Development and Clearance of a fully integrated Operating Theater for an Operating/Surgery Hospital Room
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MEDICAL TECHNOLOGIES
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Function: ALM-PLM Consultancy&Planning&Implementation, Systems Engineering Leading / Risk Management Engineering / Regulatoy Affairs Support / DMS / Clearance Support.
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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)
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2019-2020: Switzerland, France, Hungary and UK + Germany.
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End Client: HAEMONETICS
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Blood Filtering Systems, Blood & Plasma Collection Systems & Blood Management Systems
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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)
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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, etc. V-Model, SCRUM, Agile
Systems ENGINEERING LEAD (additional tasks: safety assurance cases leading / requirements engineering regulatory affairs / risk management /quality engineering )
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2017-2018, Germany & Switzerland
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End Clients: YPSOMED
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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)
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MEDICAL TECHNOLOGIES (Class 2 device) and PHARMA (Combination Products)
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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: Systems Engineering Lead / 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
-
Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / V-Model, Agile, Scrum, UML, SysML
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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 ENGINEER (additional tasks: SW quality & design engineer / requirements management / regulatory affairs)
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2016-2017, France
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End Client: ZIMMER BIOMET
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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.
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MEDICAL TECHNOLOGIES (Class 2b device)
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Function: Systems Engineering / Requirements Management / ALM-PLM Consultancy&Planning&Implementation / Regulatory Affairs Support / DMS / Clearance Support / RIMS / Postmarket / Cinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / MES
-
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
Systems ENGINEERING TEAM 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.
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ALM-PLM Consultancy&Planning&Implementation, Presentations, coaching of development; checklists, templates and process definition.
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FMEA (and DFMEA/FMEDA) Issuing and Moderation, Cyber-Security, Audits.
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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
REQUIREMENTS ENGINEERING-MANAGEMENT / QUALITY & DEVELOPMENT ENGINEER / REGULATORY AFFAIRS
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2013-2014.
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End Client: B. BRAUN
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Project: DHF Remediation activities / Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / FDA-clearance and improvement of existing Infusion Pump Systems.
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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
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Function: Requirements Engineering / Regulatory Affairs Support / Clearance Support / Postmarket / 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
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2012-2013.
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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.
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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. CAPAs / LIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / FDA 21 CFR 803 & 806. / Test Case Derivation, Development, Execution and Reporting
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Function: Systems Engineer / HW & SW Development / Requirements Engineer / Regulatory Affairs Support / Clearance Support / Postmarket / Cinical 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
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2011-2012, Baden-Württemberg, GERMANY.
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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.
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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
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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
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2011, GERMANY.
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MS Project, MS Power Point, IBM/Telelogic Rational DOORS
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Multi-site (& multi-country) Team Leading. 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 , 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
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2010-2011, GERMANY .
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SAFETY CRITICAL SYSTEMS.
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Requirements Engineering / Test Case Derivation, Development, Execution and Reporting
REQUIREMENTS MANAGER -HP QUALITY CENTER- AND SYSTEMS & SW ARCHITECT
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2010-2011, SWITZERLAND.
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End Client: METTLER-TOLEDO
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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
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PHARMA / MEDICAL TECHNOLOGIES / WiFi / PRECISION MEASUREMENT ELECTRONICS.
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Function: Requirements Engineering / Regulatoy Affairs Support / Clearance Support / Postmarket / Cinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management
SOFTWARE ARCHITECTURE & DESIGN, REQUIREMENTS, PROGRAMMING, TESTING
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2009-2010, GERMANY.
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End Client: SIEMENS HEALTHCARE
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Project: Development of a medical in-vitro diagnosis (IVD) of blood coagulation through optical technology.
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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
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2008, Independent Agent.
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IMPORT-EXPORT BUSINESS.
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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
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2004-2008, GERMANY.
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Company: FRAUNHOFER INSTITUTE IPMS (Dresden)
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MEDICAL TECHNOLOGIES / PHARMA . Video Camera for Medical Applications / Optics / GxP
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Team Leading / Software and Hardware Architecture, Development and Testing / ORCAD, WiFi, C, C++, MATLAB, Java
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Company: Fraunhofer Institute IPMS, GERMANY.
OTHER FORMER ROLES
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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
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2003. ELECTRONICS FOR RESEARCH ON PHYSICS / PRECISION MEASUREMENT ELECTRONICS. ROLE: Hardware Designer & Developer –VHDL-
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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
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2001-2002. Fields: Laser / OPTICS RESEARCH / MODELLING & SIMULATION.
Certifications
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
Local Availability
Open to travel worldwide
Available for projects worldwide. But ideally in or close to Valencia (Spain) or Frankfurt (Germany).--
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