Holger B. - Consultant for development-related topics and standards

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Stuttgart, Germany

Experience

Jun 2024 - Sep 2024

4 months

Consultant for development-related topics and standards

Maschinenbau

Standard research "product-/project-related for variable-speed pumps".
Support of internal development departments on national and international standards issues.
Creation and maintenance of internal standards and test plans.
Generation of technical requirements from normative regulations.
Cooperation with authorities.
Coordination with associations and organizations/authorities (VDE, UL, notified body EMC test).

Jan 2024 - May 2024

5 months

Development Engineer

Pari

Revision and preparation of verification-related development documents (Design Input Requirements, Traceability Matrix, V&V Plan, V&V Report) to complete the Design History File (DHF).
Determination of required tests to prove production readiness of component changes.
Planning, coordination and documentation of pending verification tests.
Execution of tests.
Regular status updates on tests in team meetings and to relevant stakeholders.
Support in preparing electrical safety tests (60601) and participation in cross-departmental root cause analyses.
Presentation of results to partners (customers/suppliers).
Planning, coordination and documentation of functional and durability studies (e.g. resistance to cleaning and disinfection).

Jul 2023 - Dec 2023

6 months

Certification Manager (Battery Storage)

SENEC GmbH

Analysis of project plan regarding schedule and target launch countries to plan required certifications.
Management and planning of certification of the ODM storage unit with accredited external labs.
Requesting quotes from accredited external labs and providing recommendations.
Creating timeline in coordination with external labs.
Tracking and updating the timeline for required certifications.
Managing the pre-test phase.
Writing standards interpretations.
Providing guidance as project contact for certification questions.
Conducting reviews and giving recommendations to approve test reports and certificates.

Jan 2023 - Jun 2023

6 months

Consultant Validation, Documentation, Testing ISO 17025 - EMC Lab

Festool GmbH

Documentation of standardized test scenarios according to ISO 17025.
Ensuring compliance with ISO 17025 when setting up a new EMC lab.
Recording, documenting and evaluating test and measurement data.
Validation of tests according to ISO 17025.

Aug 2022 - Nov 2022

4 months

Support MDR Project HF Instruments (EMC / Electrical Safety)

Ovesco Endoscopy AG

Creation of an MDR-compliant technical product documentation for one of the high-frequency instruments based on existing MDD documentation for submission to the notified body.
Preparing an expert report on 60601 family requirements for the products.
Comparison of FTRD and HF instruments to justify why FTRD results apply to HF instruments.

Nov 2021 - Jul 2022

9 months

Legal Manager/Certification Manager

Bosch ebike Systems

As-is analysis of display units, control units and radio modules and their target functions, including technical queries with technical leads and product owners.
Definition and analysis of standards, laws, norms and other regulations relevant for approvals in target markets based on product features.
Documentation of standards, laws, norms and regulations in JAMA.
Derivation of product requirements from identified standards, laws, norms and regulations for various target markets.
Documentation of requirements in JAMA.
Definition of product tests from requirements proving approval compliance and documentation in JAMA.
Test documentation in JAMA.
Logging defects in JIRA and informing the responsible requirements manager.
Creating an approval process plan based on requirements and tests.
Coordinating product approvals for various target markets by preparing prototypes in JAMA and tracking status at institutes.
Detailed technical documentation.
Preparing and creating release documents (e.g. DoCs).
Meetings with technical leads (hardware, mechanics, software) focusing on implementing approval requirements.
Legal requirement reviews of products.
Biweekly project reports on progress.

Aug 2021 - Oct 2021

3 months

Verification and Validation Engineer

Baxter

Independent documentation in English of product-specific components and modules in Word and Excel.
Independent analysis of existing requirement documents and derivation of verification documents (V&V Plan, protocol, report).
Creation of trace documents to prove requirement fulfillment.
Conducting reviews.
Technical discussions with the project team.

Feb 2021 - May 2021

4 months

Functional Safety ISO 26262

SET GmbH – Smart Embedded Technologies

Creation of specifications for electrical and mechanical test systems according to ISO 26262 in autonomous driving (steering).
Development of test procedures to validate these specifications.
Writing use cases based on defined keywords.
Documentation in a requirements management tool.
Qualification of tools/test procedures.
Direct communication with OEM.

Jan 2020 - Apr 2020

4 months

Support Project Management (JIRA)

Fresenius Medical Care

Independent research of known content to track the scope of verification in the project.
Entering gathered information organized by areas (Epic, Task, Sub-Task).
Creation of required deliverables in the project.
Linking JIRA elements.
Scheduling work packages with the test manager.

Dec 2019 - Dec 2020

1 year 1 month

Verification and Validation Engineer

Stryker Leibinger

Independent derivation and creation of test plans and criteria based on requirement documents.
Definition of test methods and equipment.
Test setup and execution.
Statistical analysis, mainly to characterize accuracy of position measurement data.
Recording results and documentation in English.
Proactive weekly reporting of project status as part of consulting.

Apr 2019 - Dec 2019

9 months

Project Manager/Work Package Lead and Test Manager Software and System Verification

Fresenius Medical Care

Project management in software and system verification.
Leading a team of 15 across locations.
Resource planning.
Technical alignment with test manager on verification strategy and with other verification units to clarify which tests each unit must perform independently in Germany and the USA.
Independent creation of all approval documents per the List of Deliverables in Polarion and beyond.
Monitoring compliance with verification processes.
Planning and assigning tasks.
Documenting project progress within the team.
Weekly planned vs. actual comparisons of verification activities with weekly reports to overall project management.
Communication with other WP leads on project activities.
Scheduling and tracking software and system verification and its maintenance.
Effort estimation.

Oct 2018 - Apr 2019

7 months

Certification Engineer Intelligent Charging Cables (E-Mobility) - Global Approval

esystems mtg ehem. bebro electronic

Planning, coordination and control of internal processes in certification.
Interface and contact for notified bodies (Intertek, 7Layers, CTC advanced).
Interface to OEMs (Porsche, Bentley).
Creation of necessary documents.
Support and advice on testing and validation topics.
Close cooperation with internal interfaces (hardware, software, mechanics).
Tracking issues (tool).
Consulting on radio and safety topics (WLAN, PLC) and EMC.
Analysis of EMC results.

Mar 2018 - Nov 2018

9 months

EMC Project Manager

Vivonic

Project management for EMC and electrical safety.
Creating project plans.
Coordination of tests at external labs and internal tests.
Supervision of internal tests.
Preparation of required documents for product approval (conformity).
Coordination of product changes due to test results.
Development and documentation of EMC measures.
Hands-on implementation of EMC measures.

Feb 2017 - Sep 2018

1 year 8 months

Test and Certification Support

viewpointsystem

Consulting on product approvals (radio, safety) and testing (environmental, electrical and mechanical tests).

Feb 2017 - Dec 2017

11 months

New Product Engineer

Philips Medizin-Systeme

APQP.
EN ISO 13485 QM system.
Process management.
Verification of production processes.
Supplier management/material planning.
Subproject work to set up a production line.
Creation of documents and specifications in APQP and supplier management.
Verification (IQ/OQ/PQ).
Risk assessment.
Creation of maintenance documentation.
Creation of work instructions.
Creation and maintenance of BOM structures.
Maintenance of PLM system.
Preparations for product launch.
Preparing product acceptance.

Jul 2016 - Jan 2017

7 months

Hardware Qualification Engineer

SMR Automotive

Successful ordering of required trades, coordination and supervision of all construction and procurement for setting up an electronics lab (ESD compliant) with four test stations.
Analysis of technical requirements.
Communication with suppliers and external service providers.
On-time and on-budget project delivery.
Technical team leadership.
Planning, coordination, execution and documentation of electrical (verification and validation) tests of all system components (control unit, camera, cables, display).
Creation of test plans and specifications.
Support of developers in specifying production tests (ICT, EOL).
Checking/supporting EMC-compliant development.
Development and creation of test strategies and concepts for a quality product.
Contribution to product strategy for core developments.
Ongoing support of hardware team on EMC, ESD, power supply protection and advanced interfaces.
Interface to external service providers.
Comparison of different implementations.
Ensuring product quality and delivery.

Sep 2014 - Jul 2016

1 year 11 months

Test and Validation Engineer Electronics

SMR Automotive

Achieved top rating (1) in BMG approval for a driver assistance system (lane change assist) for a major German automaker; full project responsibility, coordination, documentation and test leadership/execution in the validation project.
Verification and validation of highly complex optical products and bus systems (driver assistance systems, ECU, camera).
Development of internal and external test specifications.
Creation of new test concepts and plans.
Technical team leadership.
Coordination of external service providers.
Active collaboration with relevant departments.
External order processing and coordination of processes.
Creation of test reports in German and English.

Mar 2012 - Aug 2014

2 years 6 months

Measurement and Test Engineer

ThyssenKrupp Presta

Independent execution of measurements to qualify EPAS steering systems.
Responsibility for test bench and measurement equipment, maintenance of mechanics, measurement components and partly hydraulics.
Evaluation and processing of measurement data with MATLAB, CANoe and Simplex Pro.
Creation of test reports.
Programming and planning of test procedures to meet quality and deadlines.

Jul 2010 - Mar 2012

1 year 9 months

EMC Test Engineer

Tesat-Spacecom

EMC measurements on spacecraft equipment up to 60 GHz following MIL-461/462 and ECSS-E-ST-20.
Independent execution of complex EMC tests on active space products.
Evaluation and processing of test data.
Setup of LISN to measure impedance profiles.
Troubleshooting test systems and units under test.
Creation of test reports in English.