Profilbild von Sergio Guillen MedTech/Pharma/Biotech Risk&QA&Reqs Mgr-Engineer / Team-Project Lead / SYS & SW & HW Architect aus Frankfurt

Sergio Guillen

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Letztes Update: 06.09.2022

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

Firma: As GmbH, Ltd, S.A. or as Freelancer
Abschluss: Engineer
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (verhandlungssicher) | englisch (verhandlungssicher) | italienisch (verhandlungssicher) | spanisch (Muttersprache)

Dateianlagen

(2021-12) CV-Automotive.doc
(2021-12) CV-Automotive.pdf
(2021-12-07) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_Leading.doc
(2021-12-07) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_Leading.pdf
(2021-12-06) CV-MT&P&MF_ForDevelopment&Testing_Roles-Short_Companies.doc
(2021-12-06) CV-MT&P&MF_ForDevelopment&Testing_Roles-Short_Companies.pdf
(2021-11-10) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_RM.doc
(2021-11-10) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_RM.pdf
(2021-11-10) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_VV.doc
(2021-11-10) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_VV.pdf
(2021-12-13) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_SysEng.doc
(2021-12-13) CV-MT&P&MF_RiM&QM&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_SysEng.pdf
(2022-06-23) CV-MT&P&MF_RiM&QM&Doc&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies.doc
(2022-06-23) CV-MT&P&MF_RiM&QM&Doc&Leading&Reqs&Test_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies.pdf
(2022-06-24) CV-MT&P&MF_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_QM&RiM&SysEng&Reqs&DocSp+Lead&ProdOwner.doc
(2022-06-24) CV-MT&P&MF_MedTech&Pharma_PlusBiomedicine&Biology_Short_Companies_QM&RiM&SysEng&Reqs&DocSp+Lead&ProdOwner.pdf

Skills

Sergio Guillen 
+49-17634975784
sergio.guillen.services@gmail.com
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EDUCATION: Master’s Degree (5-year worldwide accepted University program) in Telecommunications Engineering – Specialties Electronics & Telecommunications, 2002, UPV Valencia, Spain


PROFESSIONAL EXPERIENCE :

- More than 10 projects in MEDICAL TECHNOLOGIES, PHARMA, BioTech and 
MEDICINE. Companies: Roche, Zimmer Biomet, Ypsomed, Haemonetics, Siemens Healthcare, Karl Storz, B.Braun, Mettler Toledo, Fraunhofer Institute, etc. More than 15 years of professional experience in international teams, mainly in Germany & Switzerland, but also in USA, Spain, France, Italy and Mexico.

- Several Audits as Lead Auditor: supplier Audits, internal Audits, mock-up Audits (ISO 13485, MDSAP, 21 CFR/FDA, 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)
Several projects in the AUTOMOTIVE branch

CERTIFICATIONS:         

- MDSAP (Medical Device Single Audit Program) – bsi Group (British Standards Institution), 2 days

- MDR training (Medical Device Regulation)
- IVDR Training (In Vitro Device Regulation)
- ISO 13485:2016, TüV Nord, 1 day
- Clinical Trials / Clinical Studies of Medical Products. 2 days, June 2018, Bonn. FORUM Institut für Management
- MDR (Medical Device Regulation) – Johner Institute, 2017-2018
- Certified Auditor (Medical Devices, ISO 13485) – Johner Institut, 2017
- Certified Risk Manager, 2015
- IREB Certified Professional for REQUIREMENTS ENGINEERING, 2010
- Certified FMEA Moderator / Moderation Formation, KVP Institut, 2017
- Certified Automotive Functional Safety Professional (AFSP) - ISO 26262 Certification (TüV Saar, Germany), 2015
- PMP - PMI Project Mgmt Certification Exam Preparation (on-going)
- Professional SCRUM Master and Professional SCRUM Product Owner, current exam preparation
- isQI CPMS (Certified Professional for Medical Software) – currently exam preparation
- iSQI ISTQB Certified Tester, currently Exam Preparation
- INCOSE Systems Engineering Professional (SEP), currently Exam Preparation

Last Conferences:         
- 2018 (2d): 2nd Annual Drug/Device Combination Products Summit
(Volanthen), Vienna
- 2018 (2days): VariantWorld 2018 (Hanser) – Variant Management for product development ..

OTHER:                        
- Seminar on Clinical Trials / Clinical Studies of Medical Products. 2 days, June 2018, Bonn. FORUM Institut für Management GmbH.
AUDIT-GARANT - Audit-Pass-Warrantor - 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
- Additional extensive Further Training and Conference/Event Attendance in the Medicine (especially in the Human Aging / Lifespan fields) and Medical Technology fields
Several days of individual Training&Coaching in Project Management, Presentation, Time Management and Soft skills, techniques and tools

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 SYS, SW & HW DEVELOPMENT:
  • Lead Auditor / Auditor (Medical Devices / Combined Products / Pharma / Automotive)
  • Medical Devices Risk Manager
  • Team Lead / PM / Scrum Master / Scrum Product Owner
  • Medical Technologies / Pharma Design and Quality Senior Engineer
  • Medical Technologies / Pharma System and Software Senior Engineer for Device Development and for DHF Creation and Remediation Activities
  • FMEA (FMEDA) Issuer / Moderator
  • Requirements Engineer (Customer & System & HW & SW Reqs)
  • Automotive Functional Safety Manager & Engineer
  • System & HW & SW Architect
  • SW Programming/Coding (mainly C++, C#, Python, embedded C/C++, SQL, Java and PHP)
  • Quoting / Quotation / In-house-development Offer Team Lead and Team Member
  • Testing
FORMER ROLES (background):
  • Quality Management and Functional Safety Manager/Engineer in the Automotive Branch
  • HW Development
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SKILLS & TECHNOLOGIES
  • Applied and theoretical knowledge of MEDICAL TECHNOLOGIES / BioTech / Engineering / PHARMA Specifications and Laws/Regulations: Design, Quality, Regulatory Affairs, 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.
  • QUALITY MANAGEMENT / PROCESS: Audits (third party audits, supplier audits, internal audits), Gap Analysis, Gap Assessment and Gap Closing Planning and Execution,  ISO 13485:2016, FMEA issuing and moderation / Experience as Quality System and Software Engineer in the MedTech branch (DHF, DMR & DHR: development and remediation activities, and CAPA) / Test Case Derivation / Supplier Quality, Supplier Management, Reporting. Experience also as project manager for process improvement and assessment preparation, in an international multi-site development scenario. V-Model, SCRUM and Extreme Programming/Agile.
  • RISK MANAGEMENT/ENGINEERING & 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.
  • 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. pharma and medical research electronic devices, in-vitro diagnostics (IVD), blood management systems, blood extraction/filtering, surgery rooms, operating theaters, minimal invasive chirurgical electro-mechanical devices -robots- for brain/spine surgery, MRT device, X-ray device, electronic insulin and blood infusion pumps, video-cameras for medical appliances).
  • 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. Real Time Image Processing. 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: GessNet Turbo-AC, KPIT Medini Analyze, APIS IQ-SW, Method Park STAGES, LINT, Coverity, QAC, Polyspace, Klocwork..
•            REQUERIMENTS ENGINEERING: IBM DOORS (+ DXL), Polarion, 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, Confluence), Subversion and CVS, Serena Team Track & PVCS, pure systems pure::variants, BigLever Gears.
•            SOFTWARE DEVELOPMENT ENVIRONMENTS, Integration and DEBUG&DIAGNOSE TOOLS: GIT, MAVEN, Jenkins, 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: Minitab, LIMS and MES (for MedTech/Pharma/BioLabs), 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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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.
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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
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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”
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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Projekthistorie

11/2020 - 12/2021
Systems Engineer
MALLINCKRODT Pharmaceuticals (>10.000 Mitarbeiter)
Pharma und Medizintechnik

SYSTEMS ENGINEERING LEAD (Additional tasks: regulatory affairs / quality&risk management) & ALM/PLM CONSULTANT

  • 2020 till End 2021, Republic or Ireland

  • End client: MALLINCKRODT Pharmaceuticals

  • 2 projects: Nitric Oxide pulmonary Delivery System (China registration) & Extracorporeal blood Photophoresis / Photopheresis System (ECP)

  • SOFTWARE & HARDWARE, Introduction of Software tools in the company, Project Planning, Cross functional interfacing (Medical, Clinical, V&V, company management, Usability, RA, Legal, Marketing, Purchasing, Engineering, Quality, Risk Mgmt), stakeholder management, ALM/PLM Consultancy&Planning&Implementation, Systems Engineering, Requirements Engineering/Management, System Architecture, Software, Risk Management, Quality Management, Documentation, Reviews. V-Model, Microsoft Project, Enterprise Architect/EA/SysML/UML, JAMA ReqEng, listing of international standards, resource planning, budgeting, regulations and guidelines applicable to the project (including the conversion of clauses into design input requirements), gap analysis. Phases: Planning, Development, Qualification & Post-Martket.

  • ISO 13485:2016, 21 CFR/FDA, ISO 9001, MDD/IVD, MDR/IVDR, ISO 14971, EN 62304, EN 62366, CSV, GxP, GMP, GCP, GLP, GAMP, MES, LIMS. V-Model, SCRUM, Agile


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

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

  • 2020, Germany

  • End client: KARL STORZ SE & Co.KG

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

  • MEDICAL TECHNOLOGIES

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

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

 

 

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

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

  • End Client: HAEMONETICS

  • Blood Filtering Systems, Blood & Plasma Collection Systems & Blood Management Systems

  • SOFTWARE & HARDWARE / Quality Management / Several Audits as Lead Auditor / 1st and 2nd party Audits of Medical Device / Pharma / Combination Products companies, Supplier Audits, Internal Audits, mock-up Audits (CE Marking, MDSAP, preparation for Notified Body Audits)

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

 

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

  • 2017-2018, Germany & Switzerland

  • End Clients: YPSOMED

  • Project: Development and Market Clearance (especially USA/FDA and EU) of different Insulin Infusion Pump Systems / Auto-injectors & Pens / SaMD (Software as a Medical Device)

  • MEDICAL TECHNOLOGIES (Class 2 device) and PHARMA (Combination Products)

  • Function: Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / Risk Manager / Supplier Management / Safety Assurance Cases / Quality Engineer / Requirements Engineer

  • Main Task/Goal: Engineering Lead / Resource planning / Introduction of Software tools in the company / Coordination of external partners and internal teams / Budgeting / Risk Management / ALM-PLM Consultancy&Planning&Implementation / CSV (Computer System Validation) / DMS / Perform Safety Assurance Cases (SACs) – including Cyber-Security -, SIEMENS MES, SIEMENS Opcenter, DMS, Labware LIMS, Preliminary Hazard Lists and Analysis, Risk Analysis, FTAs and FMEAs; DHF, DMR & DHR; SACs: in the case of insulin pumps, based on “Infusion Pumps Total Product Life Cycle, Guidance for Industry and FDA Staff” (December 2, 2014). RIMS / Additional norms/guidances/papers applied/used: Papers on cybersecurity, ISO 14971 / ISO 15026 / MDD, MDR / AAMI TIR32 / AAMI TIR57 / 21 CFR 820 / ISO 13485 / LIMS Labware / IEC 62304 / IEC 60601 / WiFi / Audits. Listing of international standards, regulations and guidelines applicable to the project, conversion of clauses into design input requirements (including assessment), gap analysis

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

  • Polarion, DOORS, Turbo-AC, etc.

  • Additional Tasks: CAPAs, interaction with the development and Regulatory Affairs teams; introduction of an appropriate SW tool for SAC performance; support of the introduction of the SAC work product and process into the company lifecycle; Cyber-Security; compilation of the Risk Management File (RMF).

 

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

  • 2016-2017, France

  • End Client: ZIMMER BIOMET

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

  • MEDICAL TECHNOLOGIES (Class 2b device)

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

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

 

 

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

  • 2014-2016, GERMANY.

  • SAFETY CRITICAL SYSTEMS.

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

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

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

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

 

PROJECT MANAGEMENT / QUALITY & DEVELOPMENT ENGINEER / REGULATORY AFFAIRS

  • 2013-2014.

  • End Client: B. BRAUN

  • Project: DHF Remediation activities / Gap Analysis, Gap Assessment and Gap Closing Planning and Execution / FDA-clearance and improvement of existing Infusion Pump Systems.

  • MEDICAL TECHNOLOGIES – DMS, Polarion, Supplier Management , RIMS, 21 CFR 820 / ISO 13485 / ISO 14971 / IEC 62304 / IEC 60601 / SIEMENS MES, SIEMENS Opcenter / WiFi / FDA clearance-approval process - FDA 21 CFR 803 / Cybersecurity / CSV / STARLIMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / FDA 21 CFR 806 / Total Product Life Cycle, test case / DHF, DMR & DHR / Audits / CAPAs / Optics

  • Function: Requirements Engineering / Regulatory Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management / V-Model / Agile / SCRUM / SysML

 

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

  • 2012-2013.

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

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

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

 

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

  • 2011-2012, Baden-Württemberg, GERMANY.

  • MS Project, IBM DOORS, MS Visio, MS Power Point, MS Excel, Atlassian JIRA & Confluence, Enterprise Architect / ISO 26262, Automotive SPICE, AUTOSAR 4, FlexRay, CAN, Python.

  • Engineering Project Manager (composed of HW-Team, SW-Team, Mech-Team, Test and Validation Teams, …), team of ca. 60 people. Multi-cultural and multi-location team (6 locations in different countries), Audits, WiFi , Cybersecurity. V-Model

  • Project Planning / Introduction of Software tools in the company / Coordination of external partners and internal teams / Resource Planning / Budgeting / MS Project. Functional Safety (ISO 26262) project leader (HW+SW) & Team Leader/Functional Owner of the FuSi-SW-Development team (ca. 8 people). Multi-location / remote team (4 locations).

 

QUALITY ASSURANCE TEAM LEAD / ASSESSMENT PREPARATION

  • 2011, GERMANY.

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

  • Multi-site (& multi-country) Team Leading. Coordination of external partners and internal teams, Gap Analysis, Gap Assessment and Gap Closing Planning and Execution. Goal of the Project: Process Improvement of a multi-site development as preparation for an Assessment. Disciplines: ALM/PLM Consultancy&Planning&Implementation , Introduction of Software tools in the company, Requirements Management, Version Control Management, Change Management, Software Development and Testing. Typical Tasks: organization of meetings and workshops (with engineers, quality managers and discipline managers), chair meetings, prepare presentation slides, hold presentations, write down minutes, hold presentations and trainings, slide preparation, business trips to sites in other countries, project planning, process analysis, coordination, arrive to agreements among the different teams, commissioning, Action Item List creation and management, Audits, Cyber-Security, V-Model.

 

REQUIREMENTS MANAGER & SOFTWARE ARCHITECT

  • 2010-2011, GERMANY .

  • SAFETY CRITICAL SYSTEMS.

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

 

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

  • 2010-2011, SWITZERLAND.

  • End Client: METTLER-TOLEDO

  • Project: Precision electronic system for liquid-powder mixing to be used in the Pharma Industry and Medical Research / Cybersecurity / CSV / LIMS / DMS / GxP / GEP / GMP / GAMP / GCP / GCP / GLP / GCLP / GDP / LabWare LIMS / Test Case Derivation, Development, Execution and Reporting / SIEMENS MES, SIEMENS Opcenter / V-Model / Agile / SCRUM

  • PHARMA / MEDICAL TECHNOLOGIES / WiFi / PRECISION MEASUREMENT ELECTRONICS.

  • Function: Requirements Engineering / Regulatoy Affairs Support / Clearance Support / Post-market / Clinical Evaluation / Clinical Trials / System & Sw Senior Quality & Design Engineer / Requirements Management

 

 

 

 

 

SOFTWARE ARCHITECTURE & DESIGN, REQUIREMENTS, PROGRAMMING, TESTING

  • 2009-2010, GERMANY.

  • End Client: SIEMENS HEALTHCARE

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

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

 

SALES / PURCHASING / IMPORT-EXPORT BUSINESS AGENT / BROKER

  • 2008, Independent Agent.

  • IMPORT-EXPORT BUSINESS.

  • Languages, People & Soft Skills, Communicability, International Relationships Management, Wide Cultural and interdisciplinary skills, Strategic thinking, Client and Partner acquisition and care, Marketing Techniques, Marketing through Internet, Email, Frequent Phone Calls and Meetings, VoIP, MS Office, MS Project.

 

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

  • 2004-2008, GERMANY.

  • Company: FRAUNHOFER INSTITUTE IPMS (Dresden)

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

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

  • Company: Fraunhofer Institute IPMS, GERMANY.

 

OTHER FORMER ROLES

  • 2004. GENETICS / BIOLOGY / BIO-LAB / MEDICAL STATISTICS / BIOSTATSTICS / BIOELECTRONICS. UAEM University and Ecology Institute of Xalapa, Mexico. ROLE: Research Bio-Engineer / GxP / GCP / GLP / GCLP

  • 2003. ELECTRONICS FOR RESEARCH ON PHYSICS / PRECISION MEASUREMENT ELECTRONICS. ROLE: Hardware Designer & Developer –VHDL-

  • 2002-2003. Software Developer and Tester FRAUNHOFER INSTITUTE IIS (research institute that developed and owns the patent of the MP3 audio format), Erlangen, GERMANY. Development of an OS-independent, multi-language, universal, flexible, light upgradable Software Speech Module for an Information System. C++ / Delphi / MATLAB / ALM-PLM Planning&Implementation

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

Reisebereitschaft

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

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

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

Versicherungsbeginn:
02.02.2011

Versicherungsende:
01.03.2023

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Profilbild von Sergio Guillen MedTech/Pharma/Biotech Risk&QA&Reqs Mgr-Engineer / Team-Project Lead / SYS & SW & HW Architect aus Frankfurt MedTech/Pharma/Biotech Risk&QA&Reqs Mgr-Engineer / Team-Project Lead / SYS & SW & HW Architect
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