Deze vacature is niet beschikbaar in je land.

Verification Engineer [F / M / X]

Amaris ConsultingEindhoven, Netherlands

30+ dagen geleden

Functieomschrijving

Job description

In this role, you will have the opportunity to :

Be part of the V erification Engineers Team , ensuring alignment with all relevant international and national regulations, including MDR and internal healthcare processes.

Participate in a cross-functional development team, representing the Verification Engineer function, and contribute to the development and execution of the standards and compliance plan.

You are responsible for :

Defining the applicable standards and regulations for products under development, such as IEC 60601 series, IEC 62304, IEC 62366-1, EU MDR , among others.
Outlining how required standards and regulations will be addressed within the Standards and Compliance plan to demonstrate compliance.
Creating and managing project deliverables related to Norm Compliance responsibilities.
Ensuring the implementation and verification of all specified legal requirements by reviewing relevant project deliverables.
Supporting designers and testers in interpreting and testing standards and regulations concerning the technical design of IGT products.
Organizing and completing all necessary evidence to obtain product certification from independent certifying agencies.
Providing technical support to the Regulatory Affairs department in preparing submissions to regulatory bodies.

To succeed in this role, you should have the following skills and experience :

A bachelor’s degree or higher in a technical field , health sciences , or a related area.

At least 3-5 years of experience in software and / or hardware testing / engineering , or in a similar role within a complex environment.

Experience in the global medical devices industry is highly desirable.

Knowledge of product safety standards (e.g., IEC 60601) is preferred.

Familiarity with other national and international regulations is an advantage.

Well-developed project management skills are preferred.

Proven experience in improvement activities and audits is beneficial.

A collaborative team player who can influence the environment to achieve project success.

If you're interested in the role but don't meet all the requirements, we still encourage you to apply ! You might be the ideal candidate for this position or other opportunities at Amaris!