Senior R&d Associate - North Duffield, United Kingdom - Kenton Black Science & Engineering

Kenton Black Science & Engineering

Verified Company

North Duffield, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Senior R&D Associate - Medical Devices

I'm working in partnership with a leading medical device manufacturer, they specialise in the design, development, and manufacture of products for the healthcare industry.

They are now looking for an R&D Associate to join the Research and Development Team.

You will be responsible for the R&D activities related to the development and launch of new medical device innovations as well as supporting the compliance of the existing medical device portfolio.

The Role:

Responsible for R&D activities related to the development and launch of new innovations.
Supporting the business in design history, product and production validation and verification and technical transfer of medical devices
Responsible for generation of documentation in the areas of design history, product and production validation and verification, usability, and technical transfer
Responsible for assisting with the generation and maintenance of SOPs and WIs related to R&D activities.
Responsible for ensuring documentation is generated for regulatory technical dossiers to agreed timelines and to a good standard.
Conducting R&D meetings to ensure projects and R&D actions are progressing.
Participating in regulatory/quality system audits (internal and external) where required.
Provide input in to change control process, impact assessments and actions required as a result of the change
Degree or equivalent certification in science related, medical, or engineering discipline
R&D experience within the medical devices sector (ideally 2 or more years' experience)
Comprehensive understanding of the MDR and medical device ISO standards, including but not limited to 13485, 14971, 10993 and 6236
Experience of working in a crossfunction project team.
Experience working with Medical Devices preferably Class I-III Devices

The Package: