Senior Medical Device Validation & Verification Consultant | Design V&V | Design Transfer | IQ/OQ/PQ | Metrologie & TMV

Ich biete umfassende Beratung in den Bereichen Validierung, Verifizierung, Designtransfer und Metrologie für Medizintechnik und stark regulierte Umgebungen.

• design transfer
• Designverifikation
• Ingenieur Gerätetechnik
• Medizintechnik
• Messtechnik
• Prozessleittechnik
• Prozessmanagement
• Qualitätsprüfer
• Risikomanagement
• validation

Senior Quality, Validation and Verification Engineer with 17+ years of experience in metrology, quality engineering, validation and regulated product development, including Medical Devices and highly regulated manufacturing environments.
I support companies throughout the product and manufacturing lifecycle, from development and Design Verification through Design Transfer, equipment qualification and process validation.

My experience combines hands-on engineering knowledge with validation strategy, risk-based qualification, test method validation, measurement systems, statistical analysis and technical documentation.

Experience working within ISO 13485, ISO 14971, MDR and FDA-regulated environments.

I am particularly interested in freelance and consulting assignments involving Medical Devices, drug-delivery systems, Design Verification, Design Transfer, NPI, laboratory/equipment qualification, process validation and metrology.
Available for European B2B consulting assignments through my company.

Working language: English; German not spoken

Senior Quality-, Validierungs- und Verifizierungsingenieur mit über 17 Jahren Erfahrung in den Bereichen Metrologie, Qualitätsingenieurwesen, Validierung und regulierte Produktentwicklung, einschließlich Medizintechnik und stark regulierte Fertigungsumgebungen. Ich unterstütze Unternehmen während des gesamten Produkt- und Fertigungslebenszyklus, von der Entwicklung und Designverifizierung über den Designtransfer, die Gerätequalifizierung bis hin zur Prozessvalidierung. Meine Expertise kombiniert praktisches Ingenieurwissen mit Validierungsstrategien, risikobasierter Qualifizierung, Testmethodenvalidierung, Messsystemen, statistischer Analyse und technischer Dokumentation. Erfahrung in ISO 13485-, ISO 14971-, MDR- und FDA-regulierten Umgebungen.

Key areas of expertise include:
• Design Verification & Validation (V&V)
• Design Transfer and NPI Quality
• Equipment Qualification – DQ / IQ / OQ / PQ
• Process Validation
• Test Method Validation (TMV)
• Metrology and Measurement System Analysis (MSA)
• Gage R&R and measurement capability studies
• Verification test strategy and protocol development
• FAT / SAT and equipment acceptance
• Risk Management and PFMEA
• Deviations, investigations and CAPA
• Statistical analysis, SPC and capability studies
• CMM and dimensional verification
• Test fixtures and measurement concepts
• Validation documentation, SOPs and work instructions

Experience working within ISO 13485, ISO 14971, MDR and FDA-regulated environments.
I am particularly interested in freelance and consulting assignments involving Medical Devices, drug-delivery systems, Design Verification, Design Transfer, NPI, laboratory/equipment qualification, process validation and metrology.


CORE TECHNICAL SKILLS
Medical Devices & Quality
ISO 13485 | ISO 14971 | EU MDR 2017/745 | Design Controls | Design Verification | Design Validation | Risk Management | CAPA | Deviations | Change Control | NPI Quality | Design Transfer
Validation & Qualification
URS | FS | DS | DQ | IQ | OQ | PQ | CQV | FAT | SAT | Process Validation | Equipment Qualification | Test Equipment Validation | Laboratory Qualification | Validation Master Planning
Testing & Metrology
Test Method Validation | MSA | Gage R&R | Type 1 / Type 2 Studies | Nested Gage R&R | CMM | GD&T | Dimensional Metrology | Tensile Testing | Measurement Capability | Test Fixtures | Measurement Strategy
Statistics & Data Analysis
SPC | Process Capability | Measurement Capability | Statistical Sampling | Minitab | JMP | Trending | Root Cause Analysis
Systems / Tools
PC-DMIS | ZEISS Calypso | Minitab | JMP | Microsoft Office

SERVICES I OFFER
Design Verification & Test Strategy
• Development of risk-based Design Verification strategies
• Verification planning and protocol development
• Definition of acceptance criteria
• Statistical sampling strategies
• Functional and dimensional testing
• Verification data analysis and reporting
• Test fixture and measurement concept support
• Traceability between requirements, risks and verification evidence
• Investigation of failed or unexpected verification results
Test Method Validation & Metrology
• Test Method Validation planning and execution
• Measurement System Analysis
• Gage R&R studies
• Measurement capability assessment
• CMM and dimensional measurement strategy
• Test equipment suitability assessment
• Statistical evaluation of measurement systems
• Development and optimization of test methods
Equipment Qualification / CQV
• Qualification strategy and risk assessment
• URS / DQ / IQ / OQ / PQ
• FAT / SAT support
• Equipment installation and acceptance
• Validation protocols and reports
• Deviations and investigation management
• Requalification and change impact assessment
Design Transfer & NPI
• Transfer of medical-device designs into manufacturing
• Manufacturing readiness assessment
• Validation planning for new equipment and processes
• Coordination between R&D, Quality, Manufacturing and suppliers
• PFMEA and process-risk activities
• Process capability and measurement-system readiness
• Support during industrialization and production ramp-up
Laboratory Qualification
• Laboratory equipment inventory and criticality assessment
• Risk-based qualification approaches
• Equipment qualification and calibration strategy
• Test equipment validation
• TMV / measurement-system qualification
• SOP and work-instruction development
• Data integrity and validation documentation

PROJECT APPROACH
I work with a structured, risk-based and practical engineering approach.
My focus is not only on completing validation documentation, but on understanding whether the equipment, process, test method or measurement system is technically capable of consistently meeting its intended requirements.