EME Medical Device Digital Technology Senior Engineer

at  Frimley Health NHS Foundation Trust

The job is very autonomous but has core values to meet which are, To work in a section of Medical Device IT solutions, KEY TASKS AND RESPONSIBILITIES To act as the essential local link for support and installation/fault finding ensuring compliance on all aspect of medical device connectivity. To work with the IT to support and give analysis of needs and future options related to medical devices. To support data control and interfacing between the Medical device and it Epr/Epic Systems, To work with Eme and It to ensure that all medical devices are both up to date , accurate and have all software levels validated. To harmonise Eme and IT asset information cross site for unified data alignment.
To ensure that on top of the software and medical device inventory all key aspects of Dimms and axons are captured for total traceability, To work and give and an understanding IT / Eme compliance under Iso 13485:2016. To work with the EME, Purchasing, Quality/Risk and other key Department to ensure that all relevant medical device IT information is kept accurate, reflects current practice, and is aligned to the departmental direction. To enhance relationships with IT in support ofan auditable medical device IT Section of the PAQ sign off process by reviewing EME conformities to NHSSC Guidelines, especially with recent changes under the Ukca criteria. To ensure that asset information as above for Medical Devices isrecorded and managed centrally on the Eme asset database.
Also validated with audits, checked, and aligned cross site. To set up a process for Equipment validation, with core Eme processes and SOPs created to cross site align workloads. To empower practices which drive consistency for EME cross site supporting CQC outcomes, 12 and 15. Development of accreditation including Sops, WIs to align to ISO 13485:2016 Medical engineering Quality Management Standards along with DSPT Compliance To act as the point of contact for in house inventory asset management.
To ensuring that the actions and requirements supporting safe and effective patient care. To be an easily identifiable and highly visible presence in the organisation as a total information and asset management medical device expert. On call rota to support cross site IT Medical device Issues. To act as the principal resource/link for clinical and managerial staff for IT connectable asset management and to provide specialist advice on the safe use of medical devices and clinical management issues contributing to a high quality, evidence-based service.
To be an easily identifiable and highly visible presence in the organisation in relation to Eme / Clinical Engineering as a PAq, Asset and IT all round Expert. To act as the principal resource/link between IT and Eme for high quality, evidence-based information related to medical devices. To analyse scenarios and documents ensuring compliance with asset information supporting whole life asset management. Support the management of medical devices 2021 auditing and compliance in accordance with IT Legal Standards and DSPT legal standards.
To Create project plans which identify areas needing change and development. To communicate information to the immediate management related to acceptable level upgrades and or software needs to be part of the complex pipeline of needs. To support government objective of implementing, RFID (Asset Tracking), UDIs (unique identification Information) GS1 (Global Standards One)and GLN (Global Location Number)and implement to FHFT cross site. To act as the Trusts representative on external working groups for the above including of UDIs (unique identification Information) GS1 (Global Standards One)and GLN (Global Location Number).
To be able to review and support solutions for PAQ complex information and validated entries, the entire process of compliance for what is and is not in date and the required actions for safety mitigation. To represent FHFT at critical user groups related to Internal/External Quality and Asset Management. To work with and uphold an accurate and up to date inventory or medical Device Connected devices within the Eme asset database for compliance and information release as needed. To critically plan workloads, To be able to create high level charting/reporting and information for the above groups.
To facilitate senior level meetings with user reports where accuracy and data quality is critical. To create documents for quality management and develop new policies , sops and build a single centralised asset setup that is both current and concise. To be responsible for creating and developing documentation in support of this role. To lead the development and specialist focus groups around the medical device PAQ, Asset Management and Quality related policies, guidelines, and protocols.
To contribute specialist expertise in the development and implementation of medical devices strategy. Maintain professional links to ensure the information and guidance relevant to national and international developments and best practices in healthcare technology ensuring communication appropriately across the Trust. Ensure there is a robust mechanism for the Safety and general software updates to be acted upon and responded to within a reasonable timescale. Make judgements requiring analysis, interpretation of options by integrating knowledge sources.
Prioritises their own workload and that of the wider team within agreed objectives deciding when to refer to others as appropriate. Works with colleagues to understand the root cause analysis and reporting accordingly within the desired course of action. To create and articulate action plans in support of the quality process creation

Please refer the Job description for details