Job summary
The Medical Equipment Management Service (MEMS) are seeking a Clinical Scientist to join our Clinical Engineering section. The post holder will act as the Trust Medical Device Safety Officer (MDSO). They will provide trust wide support for medical device incident reporting and learning, and manage the trust response to medical equipment related safety alerts. Duties include liaison with equipment users, the MHRA, equipment providers and professional bodies.
Significant knowledge and experience of working in the area of medical device safety is essential, along with experience of project management and the delivery of change/transformation within a healthcare setting.
You will be an excellent communicator with the ability to manage a complex workload which spans across multiple stakeholders from many different disciplines within healthcare.
Main duties of the job
The Medical Equipment Management Service (MEMS) provides a comprehensive service to the Trust. It comprises 4 sections; Electronics and Mechanical Workshop, Medical Equipment Training, Equipment Library and Clinical Engineering. The latter group is principally responsible for medical device governance across the organisation.
This post is based within the Clinical Engineering section. The post holder will act as the Trust Medical Device Safety Officer (MDSO). They will provide trust wide support for medical device incident reporting and learning, and manage the trust response to medical equipment related safety alerts, acting as the main contact for the MHRA and device manufacturers. They will provide technical expertise to incident investigations relating to medical devices, support the implementation of corrective actions and ensure learning from incidents is shared across the organisation.
In conjunction with the Head of Clinical Engineering, the postholder will develop medical device governance for the Trust, creating a programme of medical device safety improvement including:
- Improving the frequency and quality of incident reports involving devices,
- Responding to nationally reported device safety initiatives,
Creating and maintaining an effective medical device inventory and safety audit programme.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
Job description
Job responsibilities
Scientific and Technical
- Adopt the role of Medical Device Safety Officer (MDSO) for the Trust (as defined by the Medicines and Healthcare Products Regulatory Agency, MHRA).
- Be the principal trust contact for medical equipment related safety alerts, supporting the Trust Head of Patient Safety, liaising with MHRA and device manufacturers in relation to safety alerts involving medical equipment.
- Lead the trust response to medical equipment related safety alerts (including manufacturer field safety notices). Interpret technical information within these alerts and develop project plans to achieve the required actions. Take responsibility for the full implementation of these plans, including assurance phases.
- Provide expert scientific and technical advice to support the investigation of adverse incidents involving medical devices. Prepare detailed reports and advise the Clinical Risk Manager, Clinical Governance representative and/or MHRA of the outcomes of complex and sensitive investigations.
- Support reporting of adverse incidents involving medical devices across the organisation.
- Impliment and manage projects across the organisation to bring about any necessary change resulting from device alerts or adverse incident investigations. Ensure learning is shared across the organisation.
- Seek and assimilate new safety or regulatory information, and subsequently act as the knowledge base for it. Where necessary, interpret primary legislation or published guidance and seek further advice from advisory or regulatory bodies.
- Provide scientific support and advice to trust management, clinical supervisors and technical staff on a range of issues relating to medical device management. This includes providing risk management advice.
- Contribute to the development and implementation of the Trusts Medical Device Policy, and continuous improvement of equipment management in general, to meet clinical governance and regulatory requirements.
- Occasionally input information of all kinds, in large quantities, to the medical equipment management database to support data change projects, or as required.
- Clinical Engineering is responsible for ensuring value from the medical equipment investment programme and for ensuring effective use of trust resources to support medical devices in the trust. The postholder will:
- Work with the head of Clinical Engineering to plan and execute cost-effective procurement and support of medical devices in the trust including evaluation of options for equipment lifecycle support.
- Work with the MEP management team to aid review of equipment provision strategy in the context of clinical need, equipment options and the trusts financial strategy.
Systems and data management
- Monitor and undertake trend analysis of medical device incidents from the trust incident reporting system, managing and escalating identified issues accordingly.
- Clinical Engineering operates and maintains the medical equipment asset register within which the full equipment lifecycle is recorded. The post holder is responsible for
- Recording the departments responses to field safety notices,
- Reporting statistics to the Head of Clinical Engineering as requested,
- Using the database to determine trends in reliability or to detect underlying faults.
- Ensure risks identified through the management of medical devices are reported, escalated and captured on the Trusts risk register.
Leadership and Management
- Line manage Clinical Engineers within a team focused on device safety (see organisation structure).
- Deputise for the Head of Clinical Engineering as required.
- Prioritise own work in accordance with Departmental and Trust priorities and external demands. Meet expected results by using own initiative and following general principles and applicable regulations, standards and guidelines.
- Act as an internal quality system auditor for Medical Physics.
- Lead Trust-wide audits of medical devices policy compliance.
Professional Research and Development
- Keep abreast of the latest technical and scientific developments and their applications in medical and associated fields.
- Enrol in appropriate Continuing Professional Development programmes.
- Attend suitable seminars and courses as part of personal development and to further the work of the Department.
- Present original work at meetings and conferences, and in publications.
- Present seminars and feedback on meetings.
- Undertake research and development projects as agreed with the Head of Clinical Engineering.
- Ensure all activities are carried out within a quality framework and meet regulatory requirements.
- Represent the Department of Medical Engineering and Physics at trust governance meetings as required including the patient safety committee and trust risk governance meetings.
Teaching and Training
- Regularly supervise the work of healthcare scientist trainees, graduate and postgraduate students.
- Teach and train staff, students and others as required on all aspects of work mentioned in this job description to an appropriate level within own knowledge.
- Write and deliver lecture material to students enrolled on KCL programmes up to MSc level.
People Management and Performance
- Lead, coach and manage the performance of the team in line with good people management practices. Ensure excellence is recognised and underperformance is addressed.
- Participate in regular performance appraisal meetings and ensure each member of the team has a clear set of objectives and development plans.
- Ensure the team is compliant with all statutory and mandatory training together with any professional training requirements, ensuring they are up to date and fully compliant.
- Manage team absences including sickness in line with Trust policy ensuring the appropriate return to work meetings occur, e-roster is updated and productivity is kept to the highest possible level.
- Identify and fill any vacancies that arise within the team in line with the Trusts recruitment policy and process.
- Identify talent and support the internal talent management process in order to attract and retain and succession plan for your people.
- Review skills mix at regular intervals in order to identify any potential opportunities to maximise resource utilisation / allocation, ensuring job descriptions are kept up to date.
- Ensure overall wellbeing of the team is maintained. Continuously support in improving the morale of the team and implementing a culture of zero-tolerance for bullying and harassment.
General
- The post holder has a general duty of care for their own health, safety and wellbeing and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Trust together with all relevant statutory and professional obligations.
- To live and role model the Kings Values of:
- Understanding you
- Inspiring confidence in our care
- Working together
- Always aiming higher
- Making a difference in our community
- To observe and maintain strict confidentiality of personal information relating to patients and staff.
- To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
- This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for email communication.
Safe Guarding
The Trust takes the issues of Safeguarding Children, Adults and addressing Domestic Abuse very seriously. All employees have a responsibilityto support the organisation in our duties by;
- attending mandatory training on safeguarding children and adults
- familiarising themselves with the Trust's processes for reporting concerns
- reportingany safeguarding child or adult concerns appropriately
Infection Control Statement
The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene procedures and requirements when in clinical areas.
The post holder has an important responsibility for and contribution to make to infection control and must be familiar with the infection control and hygiene requirements of this role.
These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all times.
Job description
Job responsibilities
Scientific and Technical
- Adopt the role of Medical Device Safety Officer (MDSO) for the Trust (as defined by the Medicines and Healthcare Products Regulatory Agency, MHRA).
- Be the principal trust contact for medical equipment related safety alerts, supporting the Trust Head of Patient Safety, liaising with MHRA and device manufacturers in relation to safety alerts involving medical equipment.
- Lead the trust response to medical equipment related safety alerts (including manufacturer field safety notices). Interpret technical information within these alerts and develop project plans to achieve the required actions. Take responsibility for the full implementation of these plans, including assurance phases.
- Provide expert scientific and technical advice to support the investigation of adverse incidents involving medical devices. Prepare detailed reports and advise the Clinical Risk Manager, Clinical Governance representative and/or MHRA of the outcomes of complex and sensitive investigations.
- Support reporting of adverse incidents involving medical devices across the organisation.
- Impliment and manage projects across the organisation to bring about any necessary change resulting from device alerts or adverse incident investigations. Ensure learning is shared across the organisation.
- Seek and assimilate new safety or regulatory information, and subsequently act as the knowledge base for it. Where necessary, interpret primary legislation or published guidance and seek further advice from advisory or regulatory bodies.
- Provide scientific support and advice to trust management, clinical supervisors and technical staff on a range of issues relating to medical device management. This includes providing risk management advice.
- Contribute to the development and implementation of the Trusts Medical Device Policy, and continuous improvement of equipment management in general, to meet clinical governance and regulatory requirements.
- Occasionally input information of all kinds, in large quantities, to the medical equipment management database to support data change projects, or as required.
- Clinical Engineering is responsible for ensuring value from the medical equipment investment programme and for ensuring effective use of trust resources to support medical devices in the trust. The postholder will:
- Work with the head of Clinical Engineering to plan and execute cost-effective procurement and support of medical devices in the trust including evaluation of options for equipment lifecycle support.
- Work with the MEP management team to aid review of equipment provision strategy in the context of clinical need, equipment options and the trusts financial strategy.
Systems and data management
- Monitor and undertake trend analysis of medical device incidents from the trust incident reporting system, managing and escalating identified issues accordingly.
- Clinical Engineering operates and maintains the medical equipment asset register within which the full equipment lifecycle is recorded. The post holder is responsible for
- Recording the departments responses to field safety notices,
- Reporting statistics to the Head of Clinical Engineering as requested,
- Using the database to determine trends in reliability or to detect underlying faults.
- Ensure risks identified through the management of medical devices are reported, escalated and captured on the Trusts risk register.
Leadership and Management
- Line manage Clinical Engineers within a team focused on device safety (see organisation structure).
- Deputise for the Head of Clinical Engineering as required.
- Prioritise own work in accordance with Departmental and Trust priorities and external demands. Meet expected results by using own initiative and following general principles and applicable regulations, standards and guidelines.
- Act as an internal quality system auditor for Medical Physics.
- Lead Trust-wide audits of medical devices policy compliance.
Professional Research and Development
- Keep abreast of the latest technical and scientific developments and their applications in medical and associated fields.
- Enrol in appropriate Continuing Professional Development programmes.
- Attend suitable seminars and courses as part of personal development and to further the work of the Department.
- Present original work at meetings and conferences, and in publications.
- Present seminars and feedback on meetings.
- Undertake research and development projects as agreed with the Head of Clinical Engineering.
- Ensure all activities are carried out within a quality framework and meet regulatory requirements.
- Represent the Department of Medical Engineering and Physics at trust governance meetings as required including the patient safety committee and trust risk governance meetings.
Teaching and Training
- Regularly supervise the work of healthcare scientist trainees, graduate and postgraduate students.
- Teach and train staff, students and others as required on all aspects of work mentioned in this job description to an appropriate level within own knowledge.
- Write and deliver lecture material to students enrolled on KCL programmes up to MSc level.
People Management and Performance
- Lead, coach and manage the performance of the team in line with good people management practices. Ensure excellence is recognised and underperformance is addressed.
- Participate in regular performance appraisal meetings and ensure each member of the team has a clear set of objectives and development plans.
- Ensure the team is compliant with all statutory and mandatory training together with any professional training requirements, ensuring they are up to date and fully compliant.
- Manage team absences including sickness in line with Trust policy ensuring the appropriate return to work meetings occur, e-roster is updated and productivity is kept to the highest possible level.
- Identify and fill any vacancies that arise within the team in line with the Trusts recruitment policy and process.
- Identify talent and support the internal talent management process in order to attract and retain and succession plan for your people.
- Review skills mix at regular intervals in order to identify any potential opportunities to maximise resource utilisation / allocation, ensuring job descriptions are kept up to date.
- Ensure overall wellbeing of the team is maintained. Continuously support in improving the morale of the team and implementing a culture of zero-tolerance for bullying and harassment.
General
- The post holder has a general duty of care for their own health, safety and wellbeing and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Trust together with all relevant statutory and professional obligations.
- To live and role model the Kings Values of:
- Understanding you
- Inspiring confidence in our care
- Working together
- Always aiming higher
- Making a difference in our community
- To observe and maintain strict confidentiality of personal information relating to patients and staff.
- To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
- This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for email communication.
Safe Guarding
The Trust takes the issues of Safeguarding Children, Adults and addressing Domestic Abuse very seriously. All employees have a responsibilityto support the organisation in our duties by;
- attending mandatory training on safeguarding children and adults
- familiarising themselves with the Trust's processes for reporting concerns
- reportingany safeguarding child or adult concerns appropriately
Infection Control Statement
The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene procedures and requirements when in clinical areas.
The post holder has an important responsibility for and contribution to make to infection control and must be familiar with the infection control and hygiene requirements of this role.
These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all times.
Person Specification
Education and Qualifications
Essential
- Good (1st or 2nd class) Honours degree in a relevant subject
- Post graduate qualification related to medical device management/safety
- Registration as a Clinical Scientist with the Health and Care Professions Council
Desirable
- Further training or experience in project management or supporting change management processes
Knowledge and Experience
Essential
- Knowledge and experience of medical equipment management techniques applied within a healthcare setting
- Experience in analysing and interpreting different situations and judging measures required to ensure compliance in areas that relate to relevant legislation
- Knowledge of adverse incident investigation techniques and experience of applying these techniques within a healthcare setting
- Experience of interpreting medical device safety alerts, development of action plans and autominous management of actions through to conclusion
Desirable
- Experience in the supervision of staff and students, including HR issues
Skills and Competencies
Essential
- Able to prioritise and manage own work and that of others
- Able to develop and manage project plans, maintaining auditable records
- Ability to analyse highly complex data, problems and situations and to develop practical and workable solutions to address them
- Competent in the use of Microsoft Office e.g Word/ Excel, Outlook
Person Specification
Education and Qualifications
Essential
- Good (1st or 2nd class) Honours degree in a relevant subject
- Post graduate qualification related to medical device management/safety
- Registration as a Clinical Scientist with the Health and Care Professions Council
Desirable
- Further training or experience in project management or supporting change management processes
Knowledge and Experience
Essential
- Knowledge and experience of medical equipment management techniques applied within a healthcare setting
- Experience in analysing and interpreting different situations and judging measures required to ensure compliance in areas that relate to relevant legislation
- Knowledge of adverse incident investigation techniques and experience of applying these techniques within a healthcare setting
- Experience of interpreting medical device safety alerts, development of action plans and autominous management of actions through to conclusion
Desirable
- Experience in the supervision of staff and students, including HR issues
Skills and Competencies
Essential
- Able to prioritise and manage own work and that of others
- Able to develop and manage project plans, maintaining auditable records
- Ability to analyse highly complex data, problems and situations and to develop practical and workable solutions to address them
- Competent in the use of Microsoft Office e.g Word/ Excel, Outlook
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
