Senior R+D Engineer - Medical Device

Senior R+D Engineer - Medical Device
Empresa:

Michael Page



Área:

Otros

Senior R+D Engineer - Medical Device

Detalles de la oferta

Improvement of the current design verification testing. Up keep of relevant standards for the single use class three device. Standards such as Biocompatibility, device standards, product risk management, packaging.

Ownership of Device risk file. As such will interact with the compliance, development team and other stake holders.

Interaction with internal and external regulatory and compliance agencies for compliance aspects of the Device products.

Trending the product market performance and providing input to design team for next generation products.

Participate in development projects and interact with Manufacturers and providers to insure the requirements are met.

Lead and drive the design verification test (DVT) for new product development and sustaining projects.

Prepare verification / validation protocols and document and release the final report.

Conduct failure investigation involving variety of destructive and nondestructive tools.

Ownership of the device requirement specification defining the reliability and compliance requirements.

BS in Mechanical, Industrial , Biomedical or other engineering fields

5 years experience of single use Sterile medical device

Relevant technical experience in related field such as manufacturing, device development.

Statistical analysis - Inferential statistics.

knowledge FMEA for medical device.

Knowledge of relevant device standards.

Experience in designing medical equipment preferred, including reliability and compliance.

Excellent leadership, interpersonal and communication skills.

Knowledge of Six Sigma preferred.

Ability to adapt to change and work in a rapidly-changing environment.

International travel required.

Medical Device company, based in Barcelona, in high growth and involved in international projects.
Attractive career path


Fuente: Bebee


Área:

  • Otros / Otros

Requisitos

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