Holger B.
Consultant for development-related topics and standards
Experience
Jun 2024 - Sep 2024
4 monthsConsultant 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 monthsDevelopment 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 monthsCertification 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 monthsConsultant 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 monthsSupport 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 monthsLegal 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 monthsVerification 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 monthsFunctional 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 monthsSupport 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 monthVerification 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 monthsProject 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 monthsCertification 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 monthsEMC 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 monthsTest and Certification Support
viewpointsystem
- Consulting on product approvals (radio, safety) and testing (environmental, electrical and mechanical tests).
Feb 2017 - Dec 2017
11 monthsNew 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 monthsHardware 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 monthsTest 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 monthsMeasurement 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 monthsEMC 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.
Languages
German
NativeEnglish
AdvancedCertifications & licenses
Agile Project Management with Scrum
ISTQB Certificate Tester Foundation Level
ISTQB
LabVIEW LabView Core 1
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