Validation and Verification engineer

What is V&V engineering

A product V&V engineer works in the medical industry to perform the testing activities on medical devices during their development as well as at the end if major product changes on the product have to be assessed.

When a company is designing and developing a device, a structured workflow shall be followed by the R&D team. As part of the R&D team, the V&V Engineer starts his work after the Design Inputs have been defined and have been translated into Design Outputs. The V&V Engineer verifies that the Design Outputs (e.g. product, technical drawings) match with the Design Input (i.e. product requirements).

What does a V&V engineer do? A day in the life of a V&V engineer

A V&V Engineer works on the testing documentation (25% of the work time) and on the execution of the testing activities (40% of the work time). The testing activities on a device are regulated by a well-structured process:

• All the verification activities that shall be performed are included in a Verification Plan, which is written focusing on which requirements has to be satisfied
• Each test must be properly planned in terms of sample size, test method, conditioning and tools needed for the test. Also, it shall be covered by a test protocol that includes all the mentioned aspects
• Each test method must be validated before conducting the test, aiming to ensure its repeatability and accuracy
• Once the test has been validated, the test can be performed following the test protocol indications. Afterward, the results of the test shall be recorded in reports, including all the encountered deviations from the protocol

It is important to highlight that all these documents are as significant as the execution of the test itself for the development process since they will be part of the technical file of the medical device.

A V&V Engineer mostly focuses on writing the mentioned documents and performing the tests (80% of the work time) while also cooperating with all the R&D team, the Design Quality team and the Regulatory Affairs team (20% of the work time).

In summary, a V&V Engineer could spend 30% of his time working remotely and 70% doing Office/Laboratory work in person. The proportion of desk to laboratory time weights Laboratory 40% vs Office 60%.

Approximately 35% of an R&D team is composed of V&V Engineers.

How much does a V&V engineer earn?

Entry-level range of salary (yearly gross income):

• ITALY: 24k € - 27k €

Top skills needed: tech and soft

To plan and execute the required tests, a V&V Engineer shall have a good mix of IT, statistics, biology and engineering skills, based on the type of product he/she is working on and the type of required verification activities. For example, common tests can involve biocompatibility, sterility, packaging endurance and accelerated aged device aiming to verify how the product's features change over time.

Soft skills: high precision in the assigned tasks, ability to handle multiple activities and meet deadlines at the same time, strong communication skills with colleagues and other teams.

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