17.10.2026 aktualisiert
100 % verfügbar
Test Validation Consultant / Product Developer Engineer for Medical Device Companies
Stuttgart, Deutschland
Weltweit
Master Mechanical Engineer Degree, Faculty of Engineering, University Lucian Blaga of Sibiu, RomaniaÜber mich
Senior Freelance Engineering Consultant with 17+ years of experience in Medical Devices, Design Verification, Test Method Validation (TMV), IQ/OQ/PQ, NPI Quality, Metrology and Product Development. Specialized in technical problem-solving, validation and engineering solutions.
Skills
Validation & Qualification Protocols (IQ/OQ/PQ)
Expertise in writing and executing Validation/Qualification Protocols (URS/IQ/OQ/PQ) for measurement and testing equipment in medical device and pharmaceutical environments, including compliance with cGMP and customer requirements.
Metrology Engineering & 3D Measurement
Extensive experience in metrology engineering, including 3D measurements using CMM systems (Calypso, PC-Dmis), GD&T, Gage R&R, and managing metrology projects for NPI and production operations within budget and timelines.
Quality Engineering & ISO Standards
Deep knowledge of ISO 13485, ISO 16949, and ISO 9001 standards, applied in medical device and automotive industries, including MSA, SPC, Minitab, data integrity, and test method validation.
Product Development & Prototyping
Hands-on experience in product conception, evaluation, designing and building prototypes, 3D printing parts, and intellectual property protection including Pro-se inventor and patent ownership.
Lean Six Sigma
Training and application of Lean Six Sigma methodologies to support process improvement and quality optimization in manufacturing and laboratory environments.
testXpert & Calypso Software
Proficiency in testXpert autoinjectors software for design verification test methods and Calypso software for coordinate measuring machine programming and inspection planning.
Statistical Process Control (SPC) & MSA
Application of Statistical Process Control and Measurement Systems Analysis using MiniTab to ensure procedural efficiency and measurement reliability.
Drug Delivery Devices
Experience working with drug delivery devices including subcutaneous self-injection devices and insulin pumps, supporting validation and quality activities in compliance with medical device standards.
Team Leading & Laboratory Management
Proven ability to lead and coach laboratory teams, manage calibration activities, identify metrology standards, and mentor lab technicians and assistants.
Continental Labs Intercomparing & Laboratory Investments
Experience in continental laboratory intercomparison activities and managing laboratory investments including equipment procurement and installation.
Expertise in writing and executing Validation/Qualification Protocols (URS/IQ/OQ/PQ) for measurement and testing equipment in medical device and pharmaceutical environments, including compliance with cGMP and customer requirements.
Metrology Engineering & 3D Measurement
Extensive experience in metrology engineering, including 3D measurements using CMM systems (Calypso, PC-Dmis), GD&T, Gage R&R, and managing metrology projects for NPI and production operations within budget and timelines.
Quality Engineering & ISO Standards
Deep knowledge of ISO 13485, ISO 16949, and ISO 9001 standards, applied in medical device and automotive industries, including MSA, SPC, Minitab, data integrity, and test method validation.
Product Development & Prototyping
Hands-on experience in product conception, evaluation, designing and building prototypes, 3D printing parts, and intellectual property protection including Pro-se inventor and patent ownership.
Lean Six Sigma
Training and application of Lean Six Sigma methodologies to support process improvement and quality optimization in manufacturing and laboratory environments.
testXpert & Calypso Software
Proficiency in testXpert autoinjectors software for design verification test methods and Calypso software for coordinate measuring machine programming and inspection planning.
Statistical Process Control (SPC) & MSA
Application of Statistical Process Control and Measurement Systems Analysis using MiniTab to ensure procedural efficiency and measurement reliability.
Drug Delivery Devices
Experience working with drug delivery devices including subcutaneous self-injection devices and insulin pumps, supporting validation and quality activities in compliance with medical device standards.
Team Leading & Laboratory Management
Proven ability to lead and coach laboratory teams, manage calibration activities, identify metrology standards, and mentor lab technicians and assistants.
Continental Labs Intercomparing & Laboratory Investments
Experience in continental laboratory intercomparison activities and managing laboratory investments including equipment procurement and installation.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2014
Sprachen
EnglischverhandlungssicherFranzösischgutRumänischMuttersprache
Projekthistorie
Idea conception and evaluation. Designing, 3D printing parts and building prototypes for new products. Intellectual Property Protection - Pro-se inventor. Licensing products.
Successfully managed NPI activities by combining Quality and Validation responsibilities for new version of the Kaleido insulin pump. Supported development by reviewing and approving product and manufacturing drawings, ensuring compliance with medical device standards. Managed validation of manufacturing and measuring equipment as well as test method validation. Collaborated with R&D, Manufacturing, Suppliers, and QA/RA to implement quality controls, mitigate risks, and ensure robust documentation.
Idea conception and evaluation. Designing, 3D printing parts and building prototypes for new products. Intellectual Property Protection - Pro-se inventor. Licensing products.