Senior TMV Engineer | Medical Device Validation & MSA

Meet Life Sciences Ltd.; Emilia-Romagna; Hybrid; EUR 26,000 - 46,000; Part time

Job summary

Meet Life Sciences Ltd. is supporting a specialist Medical Device consultancy by recruiting a Senior Test Method Validation (TMV) Engineer for an immediate contract in Italy.

The role demands extensive hands-on TMV, MSA and Gage R&R experience in a regulated manufacturing environment. You will lead validation activities from protocol development through analysis and reporting, work with Engineering, Manufacturing and Quality teams, and ensure ISO 13485 compliance.

Qualifications

• Extensive hands-on TMV experience, ideally within Medical Devices.
• Knowledge of ISO 13485 and regulated manufacturing environments.
• Availability for a part-time contract requiring on-site support in Italy.

Responsibilities

• Lead the development and execution of Test Method Validation protocols.
• Conduct MSA, Gage R&R, repeatability and reproducibility studies.
• Define acceptance criteria and evaluate test method performance using statistical analysis.
• Analyse validation data using Minitab or equivalent software.
• Prepare validation reports and technical documentation.
• Collaborate with Engineering, Manufacturing and Quality teams to resolve validation challenges.
• Ensure compliance with applicable medical device quality standards, including ISO 13485.
• Extensive hands-on TMV experience, ideally within Medical Devices.
• Proven ability to independently plan, execute and interpret MSA and Gage R&R studies.
• Strong statistical analysis skills, including Minitab or equivalent software.
• Experience developing validation protocols, defining acceptance criteria and preparing technical reports.
• Knowledge of ISO 13485 and regulated manufacturing environments.
• Availability for a part-time contract requiring on-site support in Italy.

Skills

Test Method Validation

Measurement System Analysis

Gage R&R

Statistical analysis

Validation protocol development

Tools

Minitab

Job description

Meet Life Sciences Ltd. is supporting a specialist Medical Device consultancy by recruiting a Senior Test Method Validation (TMV) Engineer for an immediate contract in Italy.

The role demands extensive hands-on TMV, MSA and Gage R&R experience in a regulated manufacturing environment. You will lead validation activities from protocol development through analysis and reporting, work with Engineering, Manufacturing and Quality teams, and ensure ISO 13485 compliance.