28 set - Reggio Emilia
Meet Life Sciences
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.
Si assicuri di leggere l'intera descrizione riportata di seguito e di candidarsi immediatamente se è affidabile/a di soddisfare tutti i requisiti.
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
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- 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. xysqume
Commitment: 20 hours per week.
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