R&D System V&V Principal Engineer, Province Of Modena Montà

R&D System V&V Principal Engineer, Province Of Modena
Montà
Piemonte, Montà

R&D System V&V Principal Engineer, Province of ModenaClient: Baxter

Location: Province of Modena, Italy

Salary: EUR 50. 000 - 70. 000

Job Reference: d82cb01964fd

Posted: 02. 03. 2025 | Expiry Date: 16. 04. 2025

Job Description:Summary The R&D System V&V Principal Engineer will play a key role in confirming through examination and providing objective evidence that the medical equipment (i. e.

Dialysis machine) complies with regulations and specifications at the system level.

You will collaborate with multidisciplinary teams of engineers and work in a dynamic environment.

What you'll be doing You'll follow all the phases of Verification and Validation at system and sub-system level of a medical product, from impact analysis through the definition of test activities to the preparation of all documentation in line with regulatory/standard requests and the QMS.

The V&V activities include:

Verification of technical requirementsValidation of intended use and user needsSafety system verification and compliance to 60601-2-16Risk Control Measures verificationLabeling and Training material verificationDevelopment of tool/test bench/test method for supporting test activitiesCollaboration on investigation, feasibility and root cause analysisActive participation in cross-functional and/or cross-sites teamsSupport on internal and external AuditManagement of instruments/toolsWhat you'll bring Master's Degree in Electronic Engineering or Biomedical EngineeringISTQB certificate is preferred5+ years of experience working in R&D, in System V&V and experience with medical device products is preferredUnderstanding of medical device product design and regulatory processesKnowledge of applicable standards and regulations (FDA, ISO and IEC)Deep knowledge of Design Control and Design Of ExperimentsFamiliarity with Electronic and Software instruments and tools used in V&V labFamiliarity with Statistical Analysis and Test Methods ValidationFamiliarity with system design, electronics, mechanical and software integrationExperience with LabView and Test Stand development is preferredAble to communicate effectively, both verbally and in writing, within an international and multi-site environmentTeamworking approach, problem-solving attitude, and ability to organize and prioritize tasks

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