Senior Test Method Validation (TMV) Engineer

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 is supporting a specialist Medical Device consultancy seeking a Senior Test Method Validation (TMV) Engineer for an immediate contract assignment in Italy.

We are looking for an experienced engineer with extensive hands‑on expertise in TMV, Measurement System Analysis (MSA) and Gage R&R within a regulated manufacturing environment.

The successful candidate will independently lead test method validation activities, from protocol development and statistical analysis through to execution and final reporting.

Key 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.

Location: Northern Italy - Hybrid, with on-site attendance required 3-4 days a month.

Duration: Initial 6 months.

Commitment: 20 hours per week.