Key Responsibilities: Test Method Validation Strategy - Assess existing laboratory test methods and product validation approaches. - - Define fit-for-purpose validation strategies based on device risk, intended use and regulatory expectations. Support the development of test method validation protocols and reports. Measurement System Assessment - Evaluate measurement systems and identify critical sources of variability. - Design and execute studies addressing: o Accuracy o Precision o Repeatability o Reproducibility o Robustness o Sensitivity
- - Perform Measurement System Analysis (MSA) (e.g. through Gage R&R; studies and/or other appropriate methodologies). Contribute to uncertainty assessment and periodical metrological check strategies of the laboratory instrumentation. Statistical Leadership - Design statistically sound validation studies. - - - Determine appropriate sample sizes and experimental designs. Apply advanced statistical methodologies such as: o ANOVA o Design of Experiments (DOE) o Gage R&R; o Attribute agreement analysis o Equivalence and comparative testing Interpret experimental data and translate findings into actionable recommendations. Collaboration with Technical Subject Matter Experts - Work closely with R&D; engineers to understand the purpose of the test and the product functionality assessed by the test method (domain knowledge acquisition). - - - Challenge assumptions and ensure that measured outputs accurately represent the physical phenomena of interest. Coach engineers and senior engineers in the application of methodical approaches to test development and validation, fostering stronger capabilities in experimental design, measurement science and promoting rigorous scientific thinking. Lead and coordinate internal engineers and senior engineers who will participate in Test Method Validation activities.
Regulatory and Quality Support - Support compliance with applicable standards and regulations. - - Provide technical rationale supporting method suitability. Support the development of the most appropriate documentation structure for the company-wide management and maintenance of the TMV, including templates, procedures, and other documents.
Skills and Experience:
Technical Skills
-
Strong foundation in: Fluid Mechanics, Transport Phenomena, Heat Transfer, Thermodynamics, Mechanical Systems, Instrumentation & Sensors.
-Deep expertise in Measurement Science and Metrology:
oMeasurement System Analysis (MSA)
oMeasurement Uncertainty
oCalibration and Traceability
oSensor Characterization
-Proven experience in Test Method Development and Validation: Accuracy, Precision, Repeatability & Reproducibility, Robustness and Sensitivity Assessment.
-Validation Planning and Execution.
-Strong knowledge of Experimental Design and Applied Statistics: DOE, ANOVA, Regression Analysis.
-Good knowledge of Minitab®️ Statistical Software is strongly recommended.
-Experience with complex performance testing systems in industries such as Aerospace, Automotive, Energy, Defense, Advanced Manufacturing, or Industrial Instrumentation.
-Ability to rapidly understand and characterize unfamiliar physical systems.
Soft & Behavioral Skills
-Scientific curiosity and passion for understanding underlying physical phenomena.
-Constructive challenger, capable of questioning assumptions and improving established practices.
-Mentorship mindset, with genuine interest in developing engineers through coaching and knowledge transfer.
-Strong problem-solving and critical-thinking skills.
-Excellent collaboration and communication abilities.
-Ability to coordinate teamwork by planning activities, anticipating risks, supporting task execution, monitoring and reporting progress.
-Intellectual humility and willingness to learn a new technical domain while contributing deep methodological expertise.
📌 TMV Lead expert (Modena)
🏢 SARACA
📍 Modena