Jürgen Hertweck - Software Project Manager; Medical Device Development, IEC 81001-5-1 Compliance

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Ottobrunn, Germany

Experience

Apr 2024 - Dec 2024

9 months

Software Project Manager; Medical Device Development, IEC 81001-5-1 Compliance

Olympus

Environment: Cybersecurity; embedded software; Design Documents; change management; SBOM, Threat Modeling, Risk Management, FDA Cybersecurity Guidance.
Coordination of the revision of device developer documentation (DHF and deliverables) regarding cybersecurity with compliance to IEC 81001-5-1 and FDA guidance for 17 medical devices. Management of supplier services in the offshore and onshore areas, review and approval, Post Market Surveillance SOP execution, management of external penetration tests, review threat modeling.

Feb 2023 - Aug 2024

1 year 7 months

Scrum Coach, Operationally Active as Scrum Master

E&L - Nexus

Environment: Azure DevOps, Confluence, C#, .NET Application, MS-Windows, medical product development.
A workshop on the introduction of Scrum was conducted. A Scrum team was established to develop Clinic WinData (a workflow-oriented reporting system). All Scrum events, artifacts, and roles were defined, and the Scrum team was supported in the role of Scrum Master.

Feb 2023 - Aug 2024

1 year 7 months

Software Project Lead, In-vitro Device Development, SW Release for P312

Roche Diagnostics GmbH

Environment: Opening and archiving samples. Software technology: Linux, C, C++, development nearshore supplier, DIN EN ISO 13485, GitLab, medical device development process, cybersecurity, Risk Management EN 14971.
Responsible for software development as part of the overall project, vendor management, process-compliant project management in medical device development, application of "SOP: Post Market Surveillance", pen-test control, pen-test planning and control, creation and release of deliverables relevant for approval, Continuous Improvement of Work Instructions.

Sep 2022 - Jan 2023

5 months

App Development for iOS 16 and Low-code Development

Environment: Swift 5.7, Xcode 14, OutSystems training and evaluation.
Development of mobile apps in Swift for iOS Devices (Sailing Trim is uploaded to Apple App Store).

Jan 2022 - Aug 2022

8 months

Project Lead of SW Development and Infrastructure Project, Scrum Coach, Vendor Management

Infineon

Scrum project. Container based web application on OpenShift. Application has a high level of cybersecurity, due to the fact that the application manages the roadmaps of all Infineon products.
Frameworks: Angular, Storybook, Node.js, TypeORM, ESLint.
Client: Several different browsers.
Project has two parts: IT and Business. Responsible for all topics of realization by a supplier (coding) and the internal IT-related project management.

Oct 2020 - Sep 2021

1 year

Project Manager Software Development of a Plug-in for Image Processing of Neurological Microscope Images

Zeiss Meditec

Windows 10 Embedded App: The plug-in is a separate medical product and is developed according to MDD and is used for the analytical image processing of a camera signal for active neuro-tissue fine structure in real time.
QM system, tools and process identical to the CONVIVO project. Some events and artifacts of Scrum applied (e.g. Daily Scrum, Retrospective, timeboxing).
Project management software development project with responsibility for project planning, reporting, and controlling, Continuous Improvement of Work Instructions.

May 2020 - Sep 2020

5 months

PL Sub-project SW Development for OP Microscope (OPMI)

Zeiss Meditec

OPMI in the field of ENT, spine and plastic-reconstructive surgery. Linux-based app for controlling the multi-axis surgical microscope with touchscreen operation, LAN, WLAN, DICOM, video management, robotics, tablet connection, subcomponents with their own firmware.
QM system and process identical to the CONVIVO project. Some events and artifacts of Scrum applied (e.g. Daily Scrum, Retrospective, timeboxing).
Project management of the software development areas: Smart service, DICOM, Linux processes, overall system performance, WLAN/LAN, tablet connection (iPad), Continuous Improvement of Work Instructions.

Sep 2019 - May 2020

9 months

Project Lead SW Development of a Medical Device

Zeiss Meditec

Win10 Embedded based application development for controlling a laser system, touch screen, LAN, WLAN, DICOM, video recording and patient management. Medical device for digital biopsy for real-time analysis with the help of digital pathological examinations of the neuro-tissue fine structure via a web portal.
Application of proprietary workflow tool for requirements, use cases, test cases, test planning and evaluation, C++, DOORS. MDR-capable process model with the creation of all deliverables and corresponding milestone gates up to the market release of the medical software product, AI components included.
Some events and artifacts of Scrum applied (e.g. Daily Scrum, Retrospective, timeboxing).
Overall responsibility for the development of a new main release for a medical product with connection to ZEISS In Vivo Pathology Suite (Cloud) compliant with MDR.

Mar 2019 - May 2019

3 months

Overall Project Lead HW, SW Development

b1 Engineering Solutions

Environment: Embedded SW, controller, OR.net, LED, tablet, GUI-Software.
Project lead for a concept and planning phase of an OR lighting system with shadow management, networking and voice control. Project with a project organization of employees and external vendors. As a PL responsible for budget, realization planning and quality.

Apr 2018 - Feb 2019

11 months

Technical Project Lead SW Development

Siemens Mobility GmbH

Environment: Offshore development, Jira, Confluence, JBOSS, Java, Oracle DB, risk management of the project and vendor management regarding implementation of new functionality.
Technical project lead of a web application project with a development team located in India. Responsible for definition of requirements and implementation, go-live and maintenance planning. Also responsible for project planning, controlling and reporting.

Oct 2017 - Mar 2018

6 months

App Development for iOS 11

Environment: Swift 4, Xcode 9, iCloud.
Implementation of an app in Swift for iOS (e.g. Sailing Trim, please refer to Apple App Store).

Jul 2015 - Sep 2017

2 years 3 months

Project Manager Medical Devices

Vectura GmbH

Improvement of the inhalator AKITA JET, project management of design changes of already launched products AKITA JET and FAVOLIR.
Business environment: Embedded system, hardware and software, Jira, Subversion, planning and controlling of external development resources, medical device development according to DIN EN ISO 13485:2016.
Project size: Vendor management.
Execution of design changes: Implementation of new languages in the device, replacement of the power supply and other components according to MDD.
Update of the design history file according to EN 60601 and implementation of newer features Product Life Cycle Models.
Product development according to FDA standards.

Jul 2014 - Jun 2015

1 year

Project Manager, Scrum Master and Project Lead for Multi Project Environment

Sixt Leasing AG

Business environment: Oracle DB, Camunda workflow engine, Agile projects (role Scrum Master), BPMN 2.0, back-end software development.
Project size: Scrum team of 7 members, project teams with 10 members.
SW project lead (planning, controlling, reporting) for feature improvement of the leasing software, e.g. the new feature Infleet/Defleet on Sixt-Shops (rent a car).
Scrum Master for developing the software product Multibid (portal for car leasing contracts of different leasing companies).
Process improvement of resource management in a multi project environment.
Modeling of portal workflow in BPMN 2.0.

Jan 2014 - Jul 2014

7 months

Development of My Own App for iOS 7 (iPhone and iPad)

Own development, Objective C.

Dec 2011 - Dec 2013

2 years 1 month

Project Manager Medical Devices

Richard Wolf GmbH

Business environment: Development according to DIN EN ISO 13485, compliant to EN 60601 standard, medium-sized enterprise, Scrum (role Product Owner).
Project size: About 10 project members, several suppliers for HW and SW.
SW project lead (planning, controlling, reporting) on:
Maintenance and improvement of the software product core.control in terms of the company own endoscopy devices, maintenance (Win 7 Embedded).
Development of a video management system used in the operating room (HW and SW) including vendor management for a joint development project.
Validation as a medical device (including all relevant tests of the required type examination) is part of the applied process reference model.
The project was conducted in accordance with the given process model and compliant with the Medical Devices Act in a DIN EN ISO 13485 certified organization.
smartOR, a BMWi-funded research and development project for the modular, integrated operating room of the future.

Aug 2011 - Nov 2011

4 months

Development of Apps for iOS 7 (iPhone and iPad)

Development.

Feb 2010 - Jul 2011

1 year 6 months

Project Manager

Infineon

Business environment: 3GPP Release 7 feature development and maintenance for protocol stack SW Rel-7 (eFACH Downlink). Group experience, application of the Infineon process model, project planning, controlling and reporting. Base band of Infineon XMM6260.
Project size: Ca. 120 MM per year in maintenance and 450 MD in development.
Responsible project manager: Planning, controlling, reporting with budget responsibility and technical management for individual Rel-7 features as well as Rel-7 maintenance. International project, project language English, offshore development (India) pro rata in the project.

Jun 2009 - Jan 2010

8 months

Development of Apps, Training in Cocoa and iOS

Development.

Apr 2008 - May 2009

1 year 2 months

Heidelberg, Germany

Project Manager

Siemens Med – Oncology

Business environment: Software development and validation for added application of the linear accelerator (Visual Studio, .NET), e.g. Prowess Panther (treatment planning system). Application of the Siemens product life cycle model.
Project size: Multiple validation projects simultaneously, software redevelopment or validation of medical software products. Initiation of an organization unit for project controlling of "Small Projects".
Program Manager Small Projects (project lead):
Project lead of several smaller SW projects, reporting, responsible for budget, organization of the project including steering of the external suppliers.
Setting up a tool for controlling multi project environment.

Jun 2005 - Mar 2008

2 years 10 months

Munich, Germany

PQM (Project Attending Quality Management)

Siemens

Business environment: Software development of placement machines (Microsoft applications, embedded software, CAN-Bus). Running measurement for improvement of CMMI level, assessments.
Project size: Up to seven different projects in parallel, software development and software maintenance projects. Projects also include supplier management for external development services. Siemens product life cycle.
Software-PQM (Project Attending Quality Management): Autonomous examination and decision of individual milestones as well as survey of the project status within quality gates as decision preparation for the management.
Coaching of project managers.
Development of guidelines in the sense of CMMI requirements, reporting, implementation of PMI standards in several project organizations.

Jul 2004 - Jan 2005

7 months

Munich, Germany

Software Project Lead (Acting Until 10/04), then Requirements Manager

Infineon

Business environment: Development of GPRS MS-Software (protocol stack, driver, OO-framework, Java, MMS, WAP, camera, MMI, MM-framework, Bluetooth, IMS, PoC).
Project size: Ca. 60 MJ, international project (similar to the previous one).
Software project lead: Responsible for all development tasks in software development and head of 11 feature managers.
Requirements manager: Responsible for recording and clarifying software requirements and tracking requirements in the database RequisitePro (Rational). Negotiation with the end customer about the realization of the requirements.

Apr 2003 - Feb 2004

11 months

Munich, Germany

Project Manager GPRS Mobile, Panasonic X60

Infineon

Business environment: Development of GPRS mobile software for customer phone Panasonic X60 with Java, MMS, WAP, VSCL, camera, color display.
Project size: 7 companies for SW/HW component supplier. Project member of the joint development projects coming from Japan, Denmark, Sweden, Switzerland, Austria and Germany.
Management of system integration issues: Responsible for leading a team to solve cross-component issues (e.g. resources, interfaces, CPU load) within the mobile software. This also included the decision to solve the problem and to negotiate with the persons responsible for the subsystems.
Change Control Board: Responsible for workflow and operative issue management.
Single point of contact for customer engineers: Responsible for training and technical support of the development engineers of the customer (MMI software).

Oct 2002 - Mar 2003

6 months

QM Consultant

Business environment: Several mid-size companies.
Project size: Up to 50 employees.
Consulting accompanying certification according to DIN EN ISO 9000 for medium-sized companies, mainly in plant construction. Implementation of PMI standards in SW development.

Dec 2001 - Jul 2002

8 months

Nuremberg, Germany

Project Manager GSM Protocol Stack

Comneon (Infineon Subsidiary)

Business environment: Protocol stack software development (GSM) for a low-cost mobile phone, target market China, project language English, involved companies from Taiwan, Denmark and Germany.
Project size: Ca. 40 project members in software development, volume of 8 million GSM phones.
Project management and project controlling on the software development side with direct negotiation and support of the customer (MMI development) as well as all companies involved in the project. The project covered all phases from scoping, analysis, design, development, testing, FTA to ramp-up and is characterized by high punctuality.

Jul 2000 - Oct 2001

1 year 4 months

Munich, Germany

Quality Manager

VIAG Interkom (today O2)

Responsible for setting up a project-specific quality management system for a new billing system developed by the external system integrator Accenture. This involved quality planning, analysis, and measurement of process and product quality. Application of best practice and PMI elements (PMBOK). The environment included development of a UMTS system stack software with about 120 developers.
Autonomous conception, realization, and implementation of process improvements in the software life cycle using TQM measures. This included verification of effectiveness, evaluation, and reporting, as well as implementing PMI standards across several projects. The environment was the IT system of a mobile telecommunication company with approximately 370 employees and a billing system.

May 2000 - Jun 2000

2 months

Training on the Technologies UML, Design Patterns, Java, Servlets, JavaServer Pages, EJB, HTML, JDK, Swing

JBuilder, Together/J, Tomcat, Linux, Windows.

Jan 2000 - May 2000

5 months

Planning of an Internet Start-up

Business environment: Medical products and services via Internet.
Technical (shop, platform, products) and commercial concept (profitability forecast, liquidity plan, investment plan) of the business model including negotiation with potential investors.

Feb 1999 - Jan 2000

1 year

Project Lead of Development of a New Main Release

Industry: Trade, logistics.
Product: Multi-level merchandise management.
Business environment: Progress V8 DB, Progress 4GL, CUI, HP-UX, LAN, Extranet.
Coordination of tasks in the project for 5 internal and 5 external team members, search and selection of five freelance developers, project size: 12 MJ, customer support for the development of further individual programs.

Aug 1998 - Jan 1999

6 months

Data Modeling of a DB Application

Industry: Trade, logistics.
Product: Multi-level merchandise management.
Business environment: Progress V8, CUI, HP-UX, LAN, ER-Win.
Selection of a tool for data modeling, re-engineering DB schemas, automatic trigger generation, forward engineering from model to DB schema.

Feb 1998 - Aug 1998

7 months

Project Leader for Construction of a Help Desk

Systemhaus

Business environment: MS SQL Server, Heat for Windows by Bendata, Windows, ODBC, Win NT Server 4.0.
Selection and customization of software, installation, definition of all business processes, documentation of business processes, training of employees.

Jan 1995 - Dec 1999

5 years

Project Management in a Nationwide Rollout Project for 100 Customer Plants

Note: This was a recurring project with a total duration of 4 months within the specified period.
Industry: Building materials.
Business environment: HP-UX, ISDN, TCP/IP, Progress RDBMS, 4GL.
Planning and controlling the rollout activities, coordination of the interests of the customer.

Jan 1995 - Dec 1999

5 years

Quality Assurance: Module and Integration Test

Note: This was a recurring project with a total duration of 12 months within the specified period.
Industry: Trade, logistics.
Product: Multi-level merchandise management.
Business environment: HP-UX, ISDN, TCP/IP, Progress RDBMS, 4GL.
Development of test scenarios, black box and whitebox test, test planning, test execution, test evaluation, test report.

May 1993 - Jan 1998

4 years 9 months

Setting Up a QM System According to DIN EN ISO 9001, Extended with TQM

Systemhaus

Business environment: Progress 4GL, Progress RDBMS, CUI, HP-UX, LAN.
Training of employees and support of projects in the implementation of a quality management system in a system house with its own software development, reorganization of business processes, documentation of the QM system, programming guidelines for a 4GL language, design guidelines of a user interface and other QM documents.

Jun 1992 - Apr 1993

11 months

Programming Individual SW Parts of a Patient Database in C++

Asoc GmbH

Product: Medical device.
Business environment: Zinc Library, PC, MS-DOS.
Implementation of object persistence.

Jan 1992 - Jun 1992

6 months

System Analysis of a Laboratory Device for Blood Analysis

Kodak AG

Product: Clinical and medical devices.
Business environment: Cadre Teamwork, Solaris, PC.
Analysis and design, international project.

Sep 1989 - Dec 1991

2 years 4 months

Software Engineering in Data Processing

Kodak AG

Product: Clinical and medical devices.
Business environment: Motorola 68HC05, 68HC11, 68000, C, Assembler, Cadre Teamwork, VMS.
System analysis, design, implementation of communication in a multiprocessor system and control of a barcode scanner, international project.

Dec 1988 - Aug 1989

9 months

HW and SW Development of an Engineering Model for the Extraction of Serum from Test Tubes

Kodak AG

Product: Clinical and medical devices.
Business environment: PC, stepper motor, lab hardware, Borland C.
International project.

Apr 1988 - Sep 1988

6 months

Diploma Thesis: Design of Single-loop Controllers for Approximate Track Models (Own Design Method)

Transferzentrum für System- und Regelungstechnik

Product: Theoretical work, invention of a new method for the design of controllers.
Business environment: C, Word 5.0, PC.

Summary

As a project manager in all areas of software engineering, I focus on the management of software development projects and other large-scale IT projects with the focus on operational project management or the quality of software development process management taking into account various methods, models, such as Scrum, CMMI, PMI, ISO 9000 or EN 13495:2016. Likewise, I am qualified for technical project management for engineering projects, too. As an interim manager, I also assume temporary responsibility for organizational units in IT. The own experience as a developer comes from the field of embedded systems and has evolved to object-oriented languages like Swift with frameworks like Cocoa.

Languages

German

Native

English

Advanced

Spanish

Advanced

Education

Oct 1984 - Jun 1988

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