Jürgen Hertweck
iOS App Development (AI-based)
Experience
iOS App Development (AI-based)
Refreco GmbH
- Development of iOS apps in Swift
- AI-supported SW development using Vibe Coding with Claude Code
- Web applications through Vibe Programming
- Use of Swift, Xcode 15, Claude Code, Proxmox, GitLab, Visual Studio Code, Cursor, Doors, ClearCase
- Use of MS Project, OpenShift, Docker, Project Server, PageMaker, CRM, MS SQL Server
- SW techniques: UML, BPMN 2.0, ERD, client/server technology
Software Project Manager
Olympus
- Coordinating the update of developer documentation (DHF deliverables) for cybersecurity
- Ensuring compliance with IEC 81001-5-1 and FDA guidance for 17 medical devices
- Managing offshore and onshore supplier services, review and approval
- Overseeing external pentests, creating threat modeling
- Introducing a post-market surveillance SOP according to project requirements
- Environment: cybersecurity, embedded software, design documents, change management, SBOM, threat modeling, risk management, FDA cybersecurity compliance
- Methods: Scrum, SAFe, PRINCE2:2009, agile methods, design thinking, PMBOK, CMMI, RUP, Siemens PLM, continuous improvement, FMEA, risk management, KPIs, internal assessments, EN IEC 81001-5-1:2022
Scrum Coach
E&L Nexus
- Conducting Scrum workshops and introducing Scrum teams
- Building an MDR and China team to develop Clinic WinData (a workflow-oriented reporting system)
- Defining and supporting all Scrum events, artifacts, and roles
- Environment: Azure DevOps, Confluence, C#, .NET application, MS Windows, medical device development
- Regulatory frameworks: EN 13485, EN 62304, EN 14971, EN 60601, EU MDR, EU GDPR, FDA
Software Project Manager
Roche Diagnostics GmbH
- SW release for Cobas p312, a computer-controlled lab instrument for sorting, opening, and archiving samples
- Development of an MDD-compliant plug-in for real-time neurological microscope imaging
- Environment: Windows 10 Embedded, Linux, C, C++, GitLab, DIN EN ISO 13485, medical device development process, cybersecurity, risk management according to EN 14971
- Use of individual Scrum artifacts: daily scrum, retrospective, timebox
- Vendor management, process-compliant project execution, post-market surveillance SOP, pentest planning and management, 510(k) compliance, SBOM, DFD, threat modeling
iOS App Development
- App development for iOS 16 and low-code development using OutSystems
- Environment: Swift 5.7, Xcode 14
- Training and evaluation of OutSystems
IT Project Manager Software Development and Infrastructure, Scrum Coach
Infineon
- Project management of software development: smart services, DICOM, Linux processes, system performance, WLAN/LAN, tablet integration (iPad)
- Development in Scrum, container-based web application on OpenShift with high security level
- Frameworks: Angular, Storybook, NestJS, TypeORM, ESLint
- Client: various browsers
Project Manager Software Development
Carl Zeiss Meditec
Deputy Project Manager Software Development for Surgical Microscope (OPMI)
Carl Zeiss Meditec
- Further development of OPMI in ENT, spine, and reconstructive plastic surgery
- Linux-based control of the multi-axis surgical microscope with touchscreen, LAN, WLAN, DICOM, video management, robotics, tablet integration
- Subcomponents with custom firmware
- QA system identical to the CONVIVO project; use of Scrum artifacts: Daily Scrum, Retrospective, Timebox
Project Manager for Software Development of a Medical Device
Carl Zeiss Meditec
- Overall responsibility for a new major release of a medical software product with cloud connection to ZEISS In Vivo Pathology Suite compliant with MDR
- Windows 10 Embedded app for control of a laser system, touch GUI, LAN, WLAN, DICOM, video recording, patient management
- Use of C++, Doors, proprietary workflow tool for requirements, use cases, test cases, test planning and evaluation
- MDR-compliant process model with deliverables and milestone reviews, integration of AI engine, use of Scrum artifacts
Overall Project Manager for Hardware, Software Development, and Mechanics
b1 Engineering Solutions
- High-level concept for an operating room lighting system with shadow management, networking, and voice control
- Implementation by external and internal service providers
- Responsible for budget, scheduling, and quality
Technical Project Manager SW Development
Siemens Mobility GmbH
- Development of a web application for risk management in all project phases from proposal to warranty
- Offshore development with Jira, Confluence, JBOSS, Java, Oracle DB
App Development for iOS 11
- Implementation of apps in Swift 4, Xcode 9, iCloud
- SW project management: planning, controlling, reporting for leasing software features Infleet/Defleet
- Scrum Master for new development of the Multibid portal
- Structuring resource and project management in a multi-project environment
- Process modeling according to BPMN 2.0
Project Manager Medical Devices
Vectura GmbH
- Further developments in the AKITA JET and FAVOLIR area ([link]
- Implementation of design changes to existing products, adding more languages, power supply adaptation, new device component development
- Updating the product design file according to EN 60601 and carrying out further developments following the product life cycle model
- Environment: embedded systems, hardware and software, Jira, Subversion, Master Control, external supplier management, DIN EN ISO 13485:2016
Project Manager, Scrum Master
Sixt Leasing AG
- Technical project management for the delivery of a web application by suppliers in India
- Setup of a multi-project environment, requirement definition, implementation, operation, go-live
- Environment: Oracle DB, Camunda workflow engine, BPMN 2.0, agile projects
Development of own iOS 7 apps
- Independent development in Objective-C for iPhone and iPad
- Project management: planning, controlling, reporting with budget responsibility and technical leadership for Rel-7 features and maintenance
- International project, project language English, offshore development (India)
Project Manager Medical Device Development
Richard Wolf GmbH
Development of own apps for iOS 7
- Independent management of several small software projects
- Reporting, budget responsibility, project organization, and coordination of external suppliers
- Introduction of a tool for multi-project management
Project Manager
Infineon
- 3GPP Release 7 feature development and maintenance for protocol stack software Rel-7 (eFACH downlink) on the XMM6260 baseband
- Project planning, controlling, and reporting according to the Infineon process model
Development of own apps
- Developed own apps and learned Cocoa and iOS
- In-house development using Scrum (Product Owner role)
- Coordinated about 10 project members and various hardware/software suppliers
Project Manager
Siemens Med – Oncology
- Further development of core.control software for endoscopy devices (Win 7 Embedded)
- New development of a video management system for the OR (hardware and software) and supplier management
- Validation as a medical device according to DIN EN ISO 13485, process model compliant with the Medical Devices Act
- Participation in the smartOR research project for the modular integrated operating room of the future
PQM (Project Quality Manager)
Siemens Electronics Assembly Systems
- Project quality management for the software development of assembly machines
- Collaboration with 7 software/hardware suppliers in a joint development organization aligned with CMMI
- Management of system integration issues and Change Control Board
Software Project Lead, Requirements Manager
Infineon
- Acting software project lead until 10/2004, then requirements manager
- Development of GPRS MS software (protocol stack, drivers, OO-framework, Java, MMS, WAP, camera, MMI, MM-framework, Bluetooth, IMS, PoC)
- Capturing and clarifying requirements in Requisite Pro, negotiating with end customers
GPRS Mobile Project Manager
Infineon
- Development of GPRS mobile phone software for the Panasonic X60 with Java, MMS, WAP, VSCL, camera, color display
- Leadership of an international project team spanning up to seven different projects
- System integration issues management, negotiation with subsystem managers
- Coaching of project managers, development of CMMI guidelines, implementation of PMI standards
Quality Management Consultant
GSM Protocol Stack Project Manager
Comneon
- Leadership of software development for the GSM protocol stack of a low-cost mobile phone for the Chinese market
- Leadership of 11 feature managers, negotiation with end customers
- Project language English, international environment
Quality Manager
VIAG Interkom
- Technical and commercial design of a billing system (profit forecast, cash flow plan, investment plan)
- IT systems in the telecommunications company, project language English
- Implementation of TQM measures and PMI standards
Quality Manager
VIAG Interkom
- Coordinating 5 internal and 5 external staff, selecting freelance developers
- Managing client projects and developing additional custom programs
Planning an internet start-up company
Data modeling of an RDB application
Implementation of a QMS
- Training staff and supporting the implementation of a QMS at a system house with its own software development
- Reorganizing business processes, documenting the QMS
- Creating programming guidelines for 4GL and design guidelines for user interfaces
Summary
As a project manager with an engineering degree and more than 25 years of experience in all areas of SW engineering, I specialize in managing SW development projects and other large-scale IT projects, focusing on operational project leadership or on the quality management of SW development processes, taking into account various methods/models/frameworks like Scrum, CMMI, PMI, ISO 9000, or EN 13485:2016.
I am certified in Prince2:2009. I am also qualified to technically manage engineering projects. A large part of my projects are in medical device development.
As an interim manager, I also temporarily take responsibility for IT organizational units. My own experience as a developer comes from embedded systems and iOS app development.
Skills
- Senior Project Manager For Sw Development And Engineering Projects
- Industry Knowledge Especially In Medical Technology, Cloud, Engineering, And Web Projects
- Scrum Master, Product Owner, And Agile Coach With Qm Training And Strong Process Understanding
- Positions: It Project Management, Interim Management, Scrum Master, Product Owner, Consulting In Process Improvements For All Sw Development Processes, Project Management, Project Controlling, Quality Management For Software Development
- Main Focus: Project Management, Project Controlling, Scrum Master, Sw Quality Management, Process Consulting, Din En Iso 9001, Training And Consulting In Scrum, Tqm, Cmmi, Prince2:2009, Agile Methods
- Technologies: Inhalation Technology, Endoscopy, Oncology, Video Management, 4g Languages, Crm, Umts, Gsm, Gprs, Microsoft, Linear Accelerators, Robotics, Control Engineering, Sata, Pcie, Hdmi / Dvi, Docker, Kubernetes
- Operating Systems: Windows, Linux, Ios, Macos, Hp-ux, Solaris, Vms
- Databases: Oracle, Progress Rdbms, Ms Sql Server, Odbc, Sql, Access
- Programming Languages: Swift, Objective-c, C/c++, Assembler, 4gl, Java, Sql, C#, Visual Basic
- Hardware: Pc (Asus/intel), Arm-based Controllers, 68hc05, 68hc11, Sun Ipc, Infineon Mobile Chipsets
- Software: Objective-c, Camunda, Jira, Ms Project, Openshift, Docker, Project Server, Pagemaker, Crm, Xcode, Lint, Ms Sql Server, Claude Code, Proxmox, Gitlab, Visual Studio Code, Cursor, Doors, Clearcase, Macos, Visual Studio .Net, Ms Office, Requisite Pro, Progress Tools, Web Applications With Vibe Programming
- Sw Techniques: Uml, Bpmn 2.0, Erd, Client/server Technology
- Methods: Sw Development, Scrum, Safe, Prince2:2009, Agile Methods, Design Thinking, Pmbok (Project Management Body Of Knowledge), Cmmi, Rational Unified Process (Rup), Siemens Plm (Product Life Cycle Management), Continuous Improvement, Fmea, Risk Management, Key Performance Indicators, Internal Assessments, Situational Project Management Approaches
- Medical Device Development: En Iec 81001-5-1:2022 Health Sw And Health It Systems Safety, Qfd (Quality Function Deployment), En 13485 - Medical Devices / Quality Management, En 62304 - Medical Device Software, En 14971 - Medical Devices - Risk Management, En 60601 - Medical Electrical Equipment, Eu Mdr - Medical Device Regulation, Eu Gdpr - General Data Protection Regulation, Regulatory Frameworks: Fda (Usa), Mdr And China
- Standards: Din En Iso 9000 Ff., En 60601-1, Iso 13485, Din En 81001-5-1, Iec 62304
Languages
Education
Diploma Engineer (FH) · Communications Engineering
Certifications & licenses
SAFe (Scalable Agile Framework): Training Implementing SAFe® (SPC)
Internal Auditor ISO 13485:2016
Prince2:2009
QM Specialist Auditor
TÜV Akademie – Rheinland
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