Profileimage by Sergio Guillen MedTech/Pharma/Biotech Risk&QA&Reqs Mgr-Engineer / Team-Project Lead / SYS & SW & HW Architect from Frankfurt

Sergio Guillen

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Last update: 06.02.2020

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

Company: As GmbH, Ltd, S.A. or as Freelancer
Graduation: Telecommunications Engineer - Master’s Degree (5-year worldwide accepted University program) in Telecommunications Engineering – Specialties Electronics & Telecommunications, 2002
Hourly-/Daily rates: show
75-200 EUR / Hour-Stunde
Languages: German (Full Professional) | English (Full Professional) | Italian (Full Professional) | Spanish (Native or Bilingual)

Keywords

Programming Usability Engineer FuSi Scrum Master Automotive EN 60601 Embedded ISO 26262 IEC 61508 Scrum EN62304 ISO 13485 ISO 14971 Usability C Functional Safety Requirements Engineering scrum product owner ASPICE 26262 Team lead Medical Engineering IREB Requirements Engineer 47/EC ISO 13845 510k MDR EN 62304 21 CFR EN 62366 EN 60601-1-6 LOINC ISO 62366 medical technologies certified requirements engineer Automotives DICOM HL7 Risk Management Solutions

Attachments

(2019-03-19) CV-MT&P&MF_FFC_WCN_Long.doc
(2019-03-19) CV-MT&P&MF_FFC_WCN_Long.pdf
(2019-06-25) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short.doc
(2019-06-25) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short.pdf
(2019-06-25) CV-MT&P&MF_ForDevelopment&Testing_Roles_PlusBiomedicine&Biology_Short.pdf
(2019-06-25) CV-MT&P&MF_ForDevelopment&Testing_Roles_PlusBiomedicine&Biology_Short.doc
(2019-06-25) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_Short.doc
(2019-06-25) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_Short.pdf
(2019-06-25) CV-MT&P&MF_ForDevelopment&Testing_Roles-Short.doc
(2019-06-25) CV-MT&P&MF_ForDevelopment&Testing_Roles-Short.pdf

Skills

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  • EDUCATION: Master’s Degree (5-year worldwide accepted University program) in Telecommunications Engineering – Specialties Electronics & Telecommunications, 2002
  • isQI CPMS (Certified Professional for Medical Software) - Exam preparation
  • 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), currently, Johner Institute
  • Audit-Pass-Warrantor / Intern Auditor / Assessor for Medical Devices (ISO 13485 / ISO 9001), preparation, Johner Institute
  • Additional extensive Further Training and Conference/Event Attendance in the Medicine (especially in the Human Aging / Lifespan Increase fields) and Medical Technology fields
  • PMP - PMI Certification Exam Preparation (on-going)
  • Certified Automotive Functional Safety Professional (AFSP) - ISO 26262 Certification (TüV Saar, Germany), 2015
  • 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
PROFESSIONAL EXPERIENCE:   

8 projects in MEDICAL TECHNOLOGIES, PHARMA and MEDICINE. More than 15 years professional experience in international teams, mainly in Germany and Switzerland, but also some time in USA, Spain, France, Italy and Mexico.


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

YEAR OF BIRTH:                            1977
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MAIN ROLES in EMBEDDED SW & HW DEVELOPMENT:
  • Medical Technologies Quality Senior Engineer / Internal Assessor
  • FMEA (FMEDA) Issuer / Moderator
  • Team Lead / PM / Scrum Master / Scrum Product Owner
  • Requirements Engineer (Customer & System & HW & SW Reqs)
  • Regulatory Affairs Engineer
  • Medical Technologies System and Software Senior Engineer for Device Development and for DHF Remediation Activities
  • Medical Technologies and Automotive Risk and Functional Safety Manager & Engineer
  • System & HW & SW Architect
  • SW Programming/Coding (mainly C++, embedded C/C++, C#, PHP and Java)
  • Quoting / Quotation / In-house-development Offer Team Lead and Team Member
 
FORMER ROLES (background):
  • Quality Management and Functional Safety Manager/Engineer in the Automotive Branch
  • HW Development
  • Tester
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SKILLS & TECHNOLOGIES
  • Applied and theoretical knowledge of MEDICAL TECHNOLOGIES / Engineering / PHARMA Specifications and Laws/Regulations: 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), FDA 21 CFR part 820. Other: DICOM, LOINC, HL7, FDA 21 CFR, ISO 9001, ISO 9003, / GxP / GEP / GMP / GAMP / GCP / GCP / GCLP / GDP, EN 60601, IEC 12207, IEC 61508, ISO 61010, LIMS.
  • 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.
  • QUALITY MANAGEMENT / PROCESS: FMEA issuing and moderation as well as experience as Quality System and Software Engineer in the MedTech branch (development and DHF remediation activities and CAPA) and experience as project manager for process improvement and Automotive SPICE (level 3) assessment preparation, in an international multi-site development scenario. IEC 15504 (SPICE), CMMI and ISO 15288, V-Model, SCRUM and Extreme Programming/Agile.
  • 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 - ISO 26262 (Road Vehicles – Functional Safety). DIA, Risk and Hazard Analysis, Functional Safety Plan, Technical Safety Concept Specification, FuSa HSI, FMEA, FMEDA, Safety Requirements Engineering, IEC 61508.
  • SYS&SW&HW ARCHITECTURE, ENGINEERING and Programming Techniques: SysML, UML Modeling, OOA, OOD, OOP (Object Oriented Architecture, Design & Programming) / AUTOSAR 4 / Model-driven Development / Automatic Code Generation / Architecture & Design Patterns / Reverse Engineering.
  • 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.
  • Areas of SPECIALIZATION in the DEVELOPMENT OF EMBEDDED SYSTEMS: Medical Devices (e.g. 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); Networks; Automotive Control Devices / Electronic Control Units (ECUs): Advanced Driver Assistance Systems (ADAS/FAS), Battery Management, ESC, ABS, IDB/IBC,  Infotainment, Automotive Body Controllers (BCMs), Lighting Systems, Electronic Steering Column Lock (ESCL) Systems, Instrument Clusters, Heating Devices, Mechatronics’ Devices (Motor Controllers...), Digital Image Processing & Analysis, Video Input & Display Systems, Video Decoding, Image & Optical Sensors, Camera Systems, Audio and Video transmission systems, Network Gateways/Bridges, Communication systems and protocols, Speech Synthesis and Information System.
  • PROGRAMMING: C++ and C programming languages for embedded systems and in Algorithmic. Also Experience with VBA, C#, PHP, MS Access Query (data base access), Assembler and Java. Libraries: Embedded OpenGL for C++, C++ Standard Template Library (STL), MATLAB for C, PERL for C (Regular Expressions) / Reverse Engineering / Refactoring.
  • QUALITY ASSURANCE & TESTING: Unit Testing, Endurance/Long-term Testing, Automatic&Managed Testing, Experience in Code Reviews and Static Rule Checkers (MISRA Rules QAC Checker, LINT, Klocwork, Coverity).
  • 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.
  • DATA BUSES: Project experience with FlexRay, CAN, FireWire, Ethernet, MOST, (embedded) PCI, USB, LVDS, LIN, I2C and others.
  • OTHER INFORMATICS SKILLS: 3D & general Modeling & Simulation.
  • Experience in the market approval (authorization) process, risk analysis and development process of medical devices.
  • Also experience in Business Management, Marketing, International Relations, Client & Partner Acquisition & Care, Presentation & People Skills, Purchasing, Tax Systems and Contract Negotiation.
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TOOLS     
•            TEAM LEADING, PROJECT MANAGEMENT & OFFICE APPS: MS Project, Microsoft Team Foundation Server (MS TFS), Actano RPLAN e3, ERPs (in general), SAP (as user), Mindjet MindManager , MS Office (Word, PowerPoint, Excel, Access, Visio) & OpenOffice.
•            FUNCTIONAL SAFETY, Process and Quality Management: KPIT Medini Analyze, APIS IQ-SW, Method Park STAGES, LINT, Coverity, QAC, Polyspace, Klocwork..
•            REQUERIMENTS ENGINEERING: IBM DOORS (+ DXL), HP Quality Center, Borland Caliber, Orcanos QPack, Banana Scrum, HOOD DESIRe, Pure::variants and Big Lever Gears for Variant Management in Requirements Engineering.
•            SW&HW ARCHITECTURE & DESIGN: Project experience with SysML & UML (IBM Rational Rhapsody, SparxSystems Enterprise Architect, MID Innovator, IBM Rational Rose, Microsoft VISIO and StarUML), e.g. Use Case, Component, Package, State Machine, Class, Activity, Interaction Diagrams.
•            Application Lifecycle Management (ALM) and VERSION Control & CHANGE & CONFIGURATION & VARIANT Management Tools: 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.
•            SOFTWARE DEVELOPMENT ENVIRONMENTS and DEBUG&DIAGNOSE TOOLS: Project experience with Eclipse, Xilinx SDK, MS Visual Studio, Freescale CodeWarrior, TI Code Composer Studio, IAR Embedded Workbench, ARM RealView Development Suite. TUX Software for Unit Testing, Tessy, IBM Rational Test Real Time (RTRT)... Vector and CAN Tools: CANopen, CANoe, CANape & CANKing, Tcl/Tk.
•            HARDWARE DEVELOPMENT TOOLS & LANGUAGES: ORCAD & EAGLE (schematics, footprints & layouts), Hyperlynx (EMC/EMV), Modelsim, VHDL, Verilog, SystemC (FPGAs) / Oscilloscope & Logic Analyzer
•            MODELLING & SIMULATION: MATLAB, Simulink, LabView. Ptolemy, Mentor Graphics ModelSim, Autodesk 3ds Max (3D Studio MAX) Design , etc.
•            GRAPHICAL PROGRAMMING: Open GL (ES) API, NVidia GPUs and Adobe Flash Lite.
•            OTHER TOOLS: D’Oxygen (for technical Documentation)
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INDUSTRIES
  • Medical Technologies / Life Sciences / Technology applied to Bio-Research / Bioinformatics
  • Also some projects in the branches: Automotive, Consumer and Industrial Electronics, Precision Measurement Devices and Telecommunications
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PROFESSIONAL EXPERIENCE
 
Main role: SYSTEM & SW SENIOR DESIGN AND QUALITY ENGINEER
 
  • Project: Development & DHF (Design History File) Remediation Activities: minimal-invasive chirurgical electro-mechanical device (robot) - innovative high-precision brain & spine SURGERY.
  • MEDICAL TECHNOLOGIES (Risk Class 2B, IIB).
  • 2016-2017.
  • 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), FDA 21 CFR part 820.
  • Regulatory Affairs: EU / USA/FDA, Australia.
  • High precision minimal-invasive Chirurgical Robot with different accessories for Spine and deep and surface brain surgery. Features/modules: robot-arm with augmented reality features for precise and minimal-invasive surgery, precise “live” internal navigation during the surgery (integrated display / video-image processing), precise body patient registration through laser and other techniques, preoperative trajectory planning, fiducial markers and triangulation cameras for “live” tracking of the coordinate system (e.g. for tracking of patient respiration and real-time adaptation of the relative coordinates system during surgery), real-time cooperation with the MRT and X-Ray devices during the surgery (and before for the patient registration and surgery planning), combination of images, video and positioning info coming from different devices during the preoperative and surgery periods.
  • System, Hardware, Mechanical and Software Level activities.
  • SYS/HW/SW/Mech Design, Usability, CAPA, Risk Management and Process / Quality Systems.
  • Medical Device distributed in USA, Europe, Australia, Japan, etc.
  • Gap Analysis between actual/present DHF (Design History File) and the target DHF fulfilling the different regulations and norms.
  • Action plan for Remediation Activities for achieving the target DHF and improving the Quality System of the company, as well for the development of a new version of the product fulfilling cleanly the different regulations and norms.
  • Development activities for the future version of the product.
  • Remediation activities at System and Software level for the current marketed version.
  • Definition of Workflows for different processes.
  • Improvement of the Quality System (Procedures, Working Instructions, Templates).
  • Architecture with SysML, UML, programming with C++ and C, Requirements Engineering with Dassault Sys. REQTIFY.
  • Verification & Validation.
 
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  • Main role: Functional Safety Manager and FUNCTIONAL SAFETY ENGINEER (ISO 26262) & also tasks in FuSa CR/SYS Requirements Engineering & FuSa SYS/SW/HW Architecture & Team Leading.
  • Projects: 
  • Battery Management Systems. VW Project. Max. ASIL C.
  • Advanced Driver Assistance Systems (ADAS/FAS – Fahrerassistenzsysteme, towards Autonomous Cars). Audi Project. Max. ASIL D.
  • Electronic Stability Control (ESC) Systems, ABS, Integrated Brake Control (IBC/IDB) Systems. Max. ASIL D.
  • Body Controller ECU with integrated Gateway. Multi-processor & Multi-core system. Daimler project. Max. ASIL C.
  • Exterior Light System projects, including Laser-LED. PSA and Jaguar-Landrover Projects. Max.ASIL C.
 
  • AUTOMOTIVE / SAFETY CRITICAL SYSTEMS (ISO 26262, max. level : ASIL D).
  • 2014-2016, GERMANY.
  • ISO 26262 Norm, Medini Analyze, APIS IQ, PTC Integrity and ReqEng, Subversion, MS Project, IBM DOORS, Enterprise Architect, IBM Rhapsody, MS Visio, MS Power Point, MS Excel, AUTOSAR.
  • ISO 26262 key person for the quotation and development phases.
  • In some of the projects: FuSa Evangelist within the company (including business trips to other different locations of the company), slides preparation and performance of ISO 26262 presentations, coaching of development, management and production staff, ISO 26262 process, checklists and templates preparation.
  • FMEA (FMEDA) issuing and moderation: APIS IQ and Medini Analyze.
  • Depending on the project, responsible, author, coordinator, reviewer and/or co-author of different work products or responsible for the whole FuSa Lifecycle: Item Definition, HARA, FSC, DIA, FuSa resources and effort estimation, negotiation with OEM, Functional Safety Plan, Impact Analysis, SYS/HW/SW Technical Safety Concept, ASIL Decomposition, FuSa Traceability, FuSa SYS-SW-HW Requirements Specs, FuSa HIS, FMEA, FMEDA, SW-Safety Analysis, FuSa Test Specs, Safety Case, FuSa Assessments, etc.
  • Architecture with SysML, UML, programming with C++ and C, Requirements Engineering with IBM DOORS and PTC Integrity.
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  • Main role: Project Manager / TEAM LEAD.
  • 2014-1017, GERMANY
  • PHARMA / MEDICAL TECHNOLOGIES / Medicine, Biology of Aging  / TRANSHUMANISM / AUTOMOTIVE.
 
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  • Team Lead / Quotation Team Member / System & SW Lead & Architect / Functional Safety / Customer Level Requirements Engineering
  • Project:  Driving Assistance System (automatic parking & automatic driving, towards full autonomous cars) & Video + Flexray/CAN Logging/Replay embedded unit. Complex Multi-SoC & Multi-processor & Multi-core system. Tier1 project for Audi.
  • AUTOMOTIVE / SAFETY CRITICAL SYSTEMS (ISO 26262, max. level : ASIL D).
  • 2014-2015, GERMANY.
  • MS Project, IBM DOORS, MS Visio, MS Power Point, MS Excel, Enterprise Architect, ISO 26262, AUTOSAR, FlexRay.
  • Complex new generation Parking and Driving Assistance ECU including ultrasonic sensors and different cameras (including night vision cameras).
  • Played a main role during the quotation phase in order to get the project nomination (among about 8 competing Tier1), preparing technical concepts and quotations / Intensive Customer and Partner Contact, Telcos, Workshop Organization and Chairing, etc. Also played a main role during the actual development phase after the nomination.
 
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  • QUALITY ENGINEER / SOFTWARE REQUIREMENTS ENGINEER + SCRUM Team Member.
  • Project: FDA-clearance and improvement of an existing Infusion Pump Systems.
  • MEDICAL TECHNOLOGIES - 21 CFR 820 / 21CFR820 / ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / FDA clearance-approval process - LIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP.
  • 2013-2014.
  • Polarion for Requirements Engineering, HL7, MS Word, MS Excel.
  • Regulatory Affairs/ Approval process: USA / FDA.
  • Gap Analysis (regulations/norms): Documentation, System, Software and Hardware.
  • Task planning and participation in the task execution resulting from the gap analysis / SW and SYS Reqs and Architecture / IEC 62304 and 60601 for clearance process.
  • Coordinate, moderate and run FMEAs and Requirement Meetings & Workshops with the relevant Stakeholders.
  • OOA/OOD Architecture with SysML & UML, OOP programming with C++ and Java, Requirements Engineering with Polarion.
  • Verification & Validation.
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  • SOFTWARE REQUIREMENTS ENGINEER + SCRUM Product Owner Deputy.
  • Project: New Development of the to date highest throughput medical in-vitro diagnosis for different diseases (HIV, Hepatitis, etc.) based on PCR technology.
  • MEDICAL TECHNOLOGIES - ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / EU & FDA clearance-approval process / LIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP.
  • 2012-2013.
  • HP Quality Center (HP-QC) for Requirements Engineering and Test Management, Microsoft Team Foundation Server (MS TFS) for SCRUM & Planning & Tracking, MS Word, MS Excel.
  • Regulatory Affairs for the approval of Medical devices: EU, Japan and USA/FDA.
  • SCRUM + Agile Development while fulfilling the Med.Tech. regulations in an overall V-Model environment:  SCRUM process followed in the project – 2 week Sprints, Backlog, Stand-up & Planning & Review & Retrospective Meetings, Product Owner, Scrum Master, etc.
  • Requirement Analyses, Software Requirement Specifications (following the best practices of Requirements Engineering and modular Architecture) and Requirements Management.
  • Setting of the Criticality of the Requirements.
  • Issue of Change Requests for Requirements.
  • Verification & Validation: HP-QC (Quality Center), etc.
  • Peer Reviewing of full Test Coverage of Software Requirements (happy paths, negative test cases, edge test cases) in Requirements based Testing methodology (as it should be in every project).
  • Methodical skills, analytical abilities in order to assess Product Requirements and break them down into more technical requirements.
  • Organize and run Requirement Meetings & Workshops with the relevant Stakeholders.
  • Frequent business trips to the location of the company in Spain.
  • Distributed & International team, therefore frequent use of video-calls and video-conferences.
  • OOA/OOD Architecture with SysML & UML, OOP programming with C++, C#  and Java, and Requirements Engineering with HP-QC (Quality Center).
 
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  • TECHNICAL PROJECT MANAGER (Engineering Product Leader - EPL), FUNCIONAL SAFETY PROJECT LEAD and TEAM LEADER OF THE FUNCTIONAL SAFETY SW-DEVELOPMENT TEAM.
  • Project: Car Body Controller + integrated Gateway (CAN, FlexRay, MOST) in a dual-core processor for VW.
  • AUTOMOTIVE / SAFETY CRITICAL SYSTEMS (ISO 26262, ASIL A & B).
  • 2011-2012, Southern Region, 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.
  • Project Leader of the Engineering Team (composed of HW-Team, SW-Team, Mech-Team, Test and Validation Teams, …), around 60 people. Multi-cultural and multi-location team (6 locations in different countries).
  • 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).
  • Participation in a 4-days external (by the customer, VW) SPICE Assessment and planning/execution of improvement measures.
  • Intensive Customer Contact. Interface between Engineering Team, Program Management, Customer and external team and partner companies.
  • Participation in the Q-FMEA / Functional Safety (FuSi) SW-FMEA / FuSi SYS-FMEA / FuSi FMEDA.
  • Coordination of prototype build and sample delivery to the customer (ca. 6 people team).
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  • HARDWARE REQUIREMENTS ENGINEER –DOORS- & Hardware Subsystem Architecture.
  • Project: Development of different Electronic Steering Column Locker (ESCL) ECUs for Renault-Nissan, VW and different Chinese car makers.
  • AUTOMOTIVE / SAFETY CRITICAL SYSTEMS.
  • 2011, Southern Region, GERMANY.
  • IBM/Telelogic Rational DOORS (inc. DXL Scripting), SparxSystems Enterprise Architect, MS Power Point, UML, SysML, SIL / ASIL, Serena Dimensions CM .
  • Create advance, content-rich, parameterized DOORS Templates for ESCL Hardware Subsystem Requirements and Architecture Specifications, Hardware Module and Submodules Requirements and Design Specifications, easily and quickly customizable for all possible ESCL systems.
  • Requirements Engineering for Functional Safety Systems – Intrinsic and extrinsic Critical Safety Designs. ASIL D Functionality (ISO 26262).
  • Create, link (traceability) and review DOORS Hardware Subsystem Requirements and Architecture Specifications, Hardware Module and Submodules Requirements and Design Specifications for several ESCL systems (Renault-Nissan, different Chinese car makers, …)
  • Variant Management for Requirements Engineering.
  • Requirements elicitation, analysis, specification, modeling (SysML-UML) and management.
  • Creation of Diagrams for the Requirements and Architecture Specifications.                                                                                                                                                                                                                                                                                                                         
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  • Quality Assurance Team Lead / Automotive SPICE (ISO 15504) Assessment preparation.
  • Project: Instruments Cluster with TFT display, focus on SW/HMI development for VW/Audi.
  • AUTOMOTIVE
  • 2011, GERMANY.
  • MS Project, MS Power Point, IBM/Telelogic Rational DOORS (+ DXL Scripts development), MS Excel, PVCS, C#, VBA, MS Access, MS Query, FlexRay.
 
  • Multisite (& multi-country) Team Leading. Goal of the Project: Process Improvement of a multi-site development as preparation for an Automotive SPICE 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.  
  • Secondary Tasks: Requirements Management: Project tracking, reporting, statistics, evolution graphics, DXL programming.  Programming in C# of a synchronization interface between a Change Management Tool and a Bug Tracking Tool.
  • International multi-site team.
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  • REQUIREMENTS ENGINEER –DOORS- & Software Architecture.
  • Project: Development and optimization of an Electronic Breaking System ECU for an OEM and a Body Control Unit (BCM) ECU for VW.
  • AUTOMOTIVE / SAFETY CRITICAL SYSTEMS.
  • 2010-2011, Northern Region, GERMANY.
  • IBM/Telelogic Rational DOORS, SparxSystems Enterprise Architect, MID Innovator, UML, SysML, AUTOSAR, SIL / ASIL, SCRUM, Serena TeamTrack / CAN Bus .
  • Requirements Management / Traceability for a Safety Critical System.
  • Requirements elicitation, analysis, specification, modeling (SysML-UML) and management .
  • Add SysML-UML Diagrams (e.g. Use Case, Component, Package, State Machine, Activity, Interaction Diagrams…) to the Requirements and Architecture Specifications.
  • International multi-site team.                                                                                                                                                                                                                                                                                                                         
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  • REQUIREMENTS ENGINEERING -HP Quality Center- and System & SW Architecture.
  • Project: Precision electronic system for liquid-powder mixing to be used in the Pharma Industry and Medical Research / LIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP.
  • PHARMA / MEDICAL TECHNOLOGIES / PRECISION MEASUREMENT ELECTRONICS.
  • 2010-2011.
  • HP Quality Center, IBM Rational Rose, MKS Integrity, MS Word, MS Excel.
  • Process definition / process control of the medicines.
  • Add new System, HW and SW Requirements to the HP Quality Center database.
  • Improvement of the quality of the existing Requirements Specifications in HP Quality Center.
  • Requirements elicitation, analysis, negotiation, specification, modeling (SysML-UML) and management.
  • Add SysML-UML Diagrams to the Requirements and Architecture Specifications.
  • Electronic Control Units (ECUs) connected through the CAN bus: precision balance, sensors, motors, robots, touch-screen.
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  • Software Architecture & Design, Requirements, Programming, Testing.
  • Project:  Development of a medical in-vitro diagnosis of blood coagulation through optical technology.
  • MEDICAL TECHNOLOGIES / SAFETY CRITICAL SYSTEMS / PRECISSION MEASUREMENT ELECTRONICS / OPTICAL TECHNOLOGIES.
  • 2009-2010, GERMANY.
  • MATLAB, C Programming, Borland Caliber (Requeriments Engineering), Enterprise Architect, Eclipse SDK (Xilinx SDK), UML, Labview, Tcl/Tk, Altova XMLSpy, Tortoise SVN (Subversion ), Xilinx Mibroblaze soft-core microprocessor…
  • Responsible of the development of the software for the main sub-system (an innovative rotating optical measurement device) of the diagnostic system.
  • Requirements / Algorithmics / Data Analysis Software / Embedded Programming.
  • MATLAB: Simulation, Modeling & Model-based Testing.
  • Endurance/Long-term Testing.
  • Authoring of technical documentation and specifications in English and in German.
  • HW / SW / Mechanic Integration Teamwork and Testing.
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  • Embedded C++ Designer & Programmer.
  • Project: Development of a new generation of a high complexity Theodolit (“Total Stations”) for precision measurements.
  • PRECISION MEASUREMENT ELECTRONICS / OPTICAL TECHNOLOGIES.
  • 2008.
  • C++,  MS Visual Studio, USB, Freescale Code Warrior, Freescale MQX RTOS, Perforce Visual Client (P4V), Freescale Coldfire V2 MCF52277 microprocessor…
  • Responsible of the development of the communication system between the main sub-system, the Angle Sensor & the Motor Control Control Units.
  • Embedded Software Design, Modeling, Simulation, Programming and Test.
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  • Sales / Purchasing / Import-Export Business Agent / Broker.
  • IMPORT-EXPORT BUSINESS.
  • 2008, Independent Agent.
  • 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.
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  • SW Development Engineer.
  • Project: Development of a high-end customizable Front Panel Multimedia Device and customization for BMW.
  • AUTOMOTIVE / INFOTAINMENT / VIDEO AND MULTIMEDIA APPLICATIONS.
  • 2007-2008, Germany.
  • Telelogic Rhapsody, Automotive SPICE, WINCE OS, Telelogic CM and Change Synergy, Telelogic DOORS, C++ and C, Embedded OpenGL ES, MS Visual Studio, MS Power Point, MS Word, TUX Software for Unit Testing and Managed Testing, IBM Rational Test Real Time (RTRT), Laboratory Equipment (Oscilloscope, Digital Analyzer, PCI Analyzer), Lotus Notes, MS SharePoint, CAN, MOST and FlexRay Buses.
  • Contribute to the software development of the customer-independent general Multimedia Platform used for car front panels.
  • Contribute to the customization of the general Multimedia Platform for a specific client (BMW).
  • International, multi-site and multi-partner development team.
  • Daily synchronization video-teleconferences with international partners (teams in the company, Adobe, NVidia, BSQUARE).
  • Requirements , Presentations, Documentation, Reporting.
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  • Systems Engineer and Programmer.
  • Project: feasibility Analysis of automotive Ethernet and comparison to MOST 150 for DAS applications, for BMW.
  • AUTOMOTIVE / FAS - DAS (Driver Assistance Systems) / Infotainment / Networks / Telecommunications / Video Applications.
  • 2007, GERMANY.
  • MS Office Tools / EAGLE / TI Code Composer Studio / C Progamming Language / MS Outlook / Laboratory Equipment (Oscilloscope, Digital Analyzer), LVDS, H.264, MPEG-2, Texas Instruments DaVinci DSP TMS320DM6437, CAN, FlexRay …
  • Programming / Development of a demo / prototype for automotive top-view video applications.
  • Low latency transmission over Automotive Ethernet/ High quality compressed video / Video-camera for automotive applications
  •  Multicultural and multi-supplier Teamwork / Reporting and Documentation.
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2004-2007. Fraunhofer IPMS, Dresden, GERMANY. 3 Projects:
  1. 2006-2007. Field: CONSUMER ELECTRONICS / TELECOMMUNICATIONS / VIDEO APPLICATIONS. Project: HW & SW development of a FireWire Network-Bridge for Home Digital Multimedia Applications in cooperation with two North American partner companies.
  • TEAM LEADER + SYSTEMS ENGINEER (Requirements -Client, System, HW & SW Requirements-, System & HW & SW Architect & Partial Project Management) / Hardware Developer -ORCAD & VHDL- and Software embedded C Programmer.
  • ESPECIAL ROLE: Actively involved in the standardization process of the international standard “Networking IEEE 1394 Clusters via UWB over Coaxial Cable”, participating in the balloting sessions & the weekly telcos in English. Active member of the Wireless Working Group of the 1394 Trade Association (TA).
  1. 2005-2006. Fields: TELECOMMUNICATIONS. Project: Modeling/Simulation. Analysis of viability of the just standardized IEEE 1394.1 network bridging system. Simulation and Modeling Theory / FireWire bus / Ptolemy / MATLAB / Simulink.
  • ROLES: Research, Modelling & Simulation Engineer
 
  1. 2004-2005. Fields: MEDICAL TECHNOLOGIES / PHARMA . Project: HW & SW development of a DCAM Video Camera with an IEEE 1394b (FireWire B) Interface (bandwidth: 800Mbps). / GxP
  • SYSTEMS ENGINEER (Hardware Developer -ORCAD & VHDL-, Software embedded C Programming, Requirements -Marketing, System, HW & SW Requirements-, Systems Engineer, System & HW & SW Architect and in the last phase Partial Project Manager) / GxP / GEP / GMP / GAMP / GCP / GCP / GCLP / GDP.
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2004. Fields: 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. Fields: ELECTRONICS FOR RESEARCH ON PHYSICS / PRECISION MEASUREMENT ELECTRONICS. Organization: CERN (European Laboratory for Particle Physics), Geneva, SWITZERLAND. Project: Architecture, Design, Programming, Simulation, Synthesis, Configuration & Test of the FPGA set (4xALTERA FPGAs) of the readout system of one sub-detector of the particle physics experiment NA60.
  • ROLE: Hardware Designer & Developer –VHDL-
  • SKILLS & TOOLS: VHDL/ ModelSim / Exemplar Logic Leonardo Spectrum / ALTERA Quartus / Visual Elite / 3D Studio MAX Design
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2002-2003. Fields: AUTOMOTIVE / INFOTAINMENT / INFORMATION SYSTEMS / SPEECH SYNTHESIS.  Direct Employee at Fraunhofer IIS (research institute that developed and owns the patent of the MP3 audio format), Erlangen, GERMANY.
  • Project: Development of an OS-independent, multi-language, universal, flexible, light upgradable Software Speech Module for an Information System.
  • SW Development Engineer (Requirements, OOA SW Designer –UML- and Software embedded C++ Programming)
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2001-2002. Fields: OPTICS RESEARCH / MODELLING & SIMULATION. Part-time job at the Optics Department of the Universidad Politécnica de Valencia, SPAIN. Tasks: modeling and simulation of experimental photonic devices using Fiber Bragg Gratings using MATLAB / C programming language.
  • ROLES: Research Engineer and C & MATLAB Programmer
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2001. Fields: STATISTICS / CONSTRUCTION ENGINEERING. Part-time job at the Statistics and Operative Research Department of Polytechnic University of Valencia, SPAIN. Tasks: build devices for educative purposes in the Statistics field/ Additional Tools: SPSS.
  • ROLES: Research Engineer
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2000-2001. Fields: SALES / IT. Part-time job at PC-Shop in Valencia, SPAIN. Tasks: Representative / Salesman / Customer Relations / Technician in a PC-Shop / PC Assembly and Sale.
 
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SOFT SKILLS
  • Wide cultural & interdisciplinary education.
  • Proactive, Flexible, adaptable, goal-oriented & open-minded.
  • Strategic thinking, teamwork, wide experience with international and multi-site teams.
  • Medicine Research passionate
  • Seeing projects through, able to work under pressure.
  • Experience in holding public speeches and presentations.
  • Agreeable on having business trips, even frequently.
  • Humorous, patient, able to head and motivate people.
 
 
_______________________________________________________________________________
SYNTHESIZED 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
 
MEDICINE / MEDICAL TECHNOLOGIES
  • 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
 
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 – Product Owner”
  • “SCRUM – Scrum Master”
 
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
  • “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”
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Project history

See them in the attached documents.--

Time and spatial flexibility

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

Contact form

Contact details