EME Medical Device Digital Technology Senior Engineer

at  Frimley Health NHS Foundation Trust

As a member of the Eme/Clinical Engineering Team, the post holder will be responsible to attend all medical device related IT connectable issues and further provide front and back end support for medical device digital issues. They will be the primary contact to assist in the trust digital medical device development , the first line team response and support all digital connectivity issues up to the EPR solution. In support of this the need to work closely with the IT department will create culture of development and drive the Eme digital strategy forward.
The post holder will act as the core responsible person to act on workloads and ensure that KPI’s are aligned to the Eme/Clinical Engineering strategy and address issues and plan accordingly to the preset expectations.
The post holder will be based on one site but will work as part of a supportive team are working as per desired guidelines and meeting the needs of the users through planning have the ability to plan with work demands . Through experience of working with medical devices should understand the responsibilities and factors involved in the safe management and support end users / customers with their planning , queries and overall be the responsible person as the face of EME services overall in the Medical Device Connectable Solutions.
With the need for compliance of medical device information to CQC outcome 15, 12 ‘Safe’ and Medical Device Management Standards 2021 and DSPT /Integration support is critical. The department of Eme and IT now needs critical alignment to ensure medical equipment software , hardware have both the ability for interfacing, analysis and complex workstreams to be developed and aligned. The role is to work as part of an IT and EME Interfacing role to give the understanding of the support and high standards with aligned underpinning knowledge FHFT Core digital and medical device values.
With need being unique the aim of the role is to have an entrepreneurial team leader with clear high-quality leadership to setup a group of Engineers that will ensure all DSPT guidance is adhered to with accurate information , assets are managed and all data is kept and update and monitored. With this the need to develop a Medical Device IT connected team is a major step in the department strategic directions so that all medical devices that could be connected with supporting plans of software updates enveloping requested solutions.
The post holder will be a vital pivotal position that is both new and innovative aligning DSPT standards with a register complaint to DSPT Guidance 2023/24 9.3.8 and 9.3.9.
There’s never been a more exciting time to build your career at Frimley Health, one of the country’s largest and most respected trusts
Frimley Health NHS Foundation Trust (FHFT) has an outstanding reputation and a proud record of achievement. We have an ongoing commitment to improving the health and care services for the 900,000 people we serve across Berkshire, Hampshire, Surrey and south Buckinghamshire.
We continue to invest in our services and facilities, including a £10 million upgrade to the hospital maternity unit as well as £49m major new Emergency Assessment Centre on our Wexham Park site. The opening of a brand new £100m state of the art hospital which replaced the existing hospital facility at Heatherwood and are planning to invest further in diagnostics and inpatient capacity at Frimley Park.
We have also made significant investment in our quality improvement and digital programmes to support our vision and we will ensure that we achieve our aim of providing the highest quality healthcare to our patients. Our new EPR – Epic – went live in June and we are already beginning to reap the benefits of this ambitious investment .
Our three core values , and the behaviours that support them, guide everything we do and set out what we expect of our staff in the way they treat patients, visitors, service users and each other.
If you have a passion for clinical excellence, patient care and your own career development, you’ll feel at home at Frimley Health.
The job is very autonomous but has core values to meet which are,
To work in a section of Medical Device IT solutions,

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 of an 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 is recorded 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 Sop’s, 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), UDI’s (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 UDI’s (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