R&D System V&V Principal Engineer, Province of Modena
Client: 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 requirements
* Validation of intended use and user needs
* Safety system verification and compliance to 60601-2-16
* Risk Control Measures verification
* Labeling and Training material verification
* Development of tool/test bench/test method for supporting test activities
* Collaboration on investigation, feasibility and root cause analysis
* Active participation in cross-functional and/or cross-sites teams
* Support on internal and external Audit
* Management of instruments/tools
What you'll bring
* Master's Degree in Electronic Engineering or Biomedical Engineering
* ISTQB certificate is preferred
* 5+ years of experience working in R&D, in System V&V and experience with medical device products is preferred
* Understanding of medical device product design and regulatory processes
* Knowledge of applicable standards and regulations (FDA, ISO and IEC)
* Deep knowledge of Design Control and Design Of Experiments
* Familiarity with Electronic and Software instruments and tools used in V&V lab
* Familiarity with Statistical Analysis and Test Methods Validation
* Familiarity with system design, electronics, mechanical and software integration
* Experience with LabView and Test Stand development is preferred
* Able to communicate effectively, both verbally and in writing, within an international and multi-site environment
* Teamworking approach, problem-solving attitude, and ability to organize and prioritize tasks
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