Main Purpose of Job
* Responsible for R&D activities related to the development and launch of new innovations.
* Responsible for R&D activities related to supporting the compliance of GBUK's existing medical device portfolio.
* Supporting the business in design history, product and production validation and verification, and technical transfer of medical devices.
* Responsible for generation and maintenance of technical documentation and the design history file to ensure compliance with all current Medical Device regulations and ISO 13485 requirements.
Main Tasks/Responsibilities
* To provide accurate and current Research & Development input to support the development and compliance of medical devices launched and marketed by GBUK.
* Responsible for generation of documentation in the areas of design history, product and production validation and verification, risk management, hazard analysis, usability, and technical transfer.
* Responsible for writing and maintaining user requirement specifications and risk analysis documentation.
* Responsible for working with external partners, such as laboratories, to run studies, ensuring the studies are planned correctly and delivered to agreed timings.
* Responsible for communicating with suppliers to ensure GxP and to keep GBUK DHFs up to date in accordance with change controls and remediation projects.
* Responsible for working as part of a cross-functional project team, in partnership with the New Product Development team to deliver new medical device innovations.
* Responsible for working as part of a cross-functional project team delivering changes to the existing portfolio of medical devices marketed by GBUK.
* 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 into the change control process, impact assessments, and actions required as a result of the change.
* To represent the company in a professional and courteous manner.
* Any other task as required by the Technical Director.
Essential
* Degree or equivalent certification in a science-related, medical, or engineering discipline.
* R&D experience within the medical devices sector (ideally 2 or more years’ experience).
* Experience in conducting V&V activities in relation to the design and manufacture of medical devices.
* Ability to assess all necessary and specific medical device regulatory obligations and to advise staff accordingly.
* Comprehensive understanding of the MDR, IVDR, and medical device ISO standards, including but not limited to 13485, 14971, 10993, and 62366.
* Experience of working in a cross-functional project team.
* Suitable general IT skills.
Desirable
* Knowledge of DFM principles.
* Experience in writing SOPs and WIs.
* Experience of working in compliance with GxP.
* Experimental skills in mechanical testing of medical devices.
Skills/Competencies
* Capable of working in a team and independently.
* Problem Solver.
* Able to project manage multiple tasks.
* Able to understand technical drawings.
* Understanding of manufacturing processes.
* Good communication skills.
* Organised working style.
* Eye for detail.
* High level of computer literacy.
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