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Base pay range
Direct message the job poster from GBUK Group Main Tasks/Responsibilities
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. To provide accurate and current Research & Development input to support with 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 DHF’s 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. Minimum Requirements
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. Have the ability to assess all necessary and specific medical device regulatory obligations and to be able 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. 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. Capable of working in a team and independently. Able to project manage multiple tasks. Able to understand technical drawings. Understanding of manufacturing processes. Organised working style. High level of computer literacy. Seniority level
Associate Employment type
Full-time Job function
Design Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
Direct message the job poster from GBUK Group Main Tasks/Responsibilities
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. To provide accurate and current Research & Development input to support with 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 DHF’s 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. Minimum Requirements
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. Have the ability to assess all necessary and specific medical device regulatory obligations and to be able 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. 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. Capable of working in a team and independently. Able to project manage multiple tasks. Able to understand technical drawings. Understanding of manufacturing processes. Organised working style. High level of computer literacy. Seniority level
Associate Employment type
Full-time Job function
Design Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
