Job summary
An exciting opportunity has arisen to join the Clinical Engineering team at University Hospitals Dorset NHS Trust. We are looking for a passionate, committed and experienced candidate for the key post of Medical Devices Governance Manager.
The Clinical Engineering Department is part of University Hospitals Dorset, working across both Poole and the Royal Bournemouth Hospitals, and is responsible for the management of a diverse range of medical equipment for two General Hospitals and many Healthcare facilities across Dorset.
You will have a degree in a relevant clinical, scientific or engineering subject, or equivalent qualification, and comparable experience as well as significant relevant experience in the management of medical devices. You will ideally have experience in the supervision and management of small teams and have a supervisory management qualification.
You will have experience in operation and function of patient-critical equipment and techniques in healthcare, in interpreting different situations and judging measures required to ensure appropriate use of technology. You will be well versed in undertaking risk assessments on medical devices and medical device incident investigations. You are customer focussed, proficient with IT systems and you have good written/verbal communications.
Base Location: Poole Hospital, but cross site working will be required
Interview Date: TBC
Main duties of the job
As Medical Devices Safety Officer for the Trust you will have a key role to play in ensuring medical devices throughout the Trust are safe and properly used.
In addition to medical device incident investigation and reporting and following up on alerts and field safety notices you will be responsible for the development of user training and for the management and development of the equipment library functions on the two main sites.
About us
Our values define who we are as #TeamUHD. They underpin everything we do now and in the future. They define how we treat our patients, visitors, and each other, our valued teammates and colleagues.
UHD are investing in services across the Trust, with many being transformed and developed following merger and the New Hospital Programme.
This means that some services may move site this year or next, either temporarily or long term. Recruiting Managers interviewing for this role will be happy to answer any specific questions that you have about this at interview.
Job description
Job responsibilities
Please see the full job description attached.
- To develop and lead the multi-professional Medical Equipment User Support team.
- Be responsible for ensuring safe, appropriate and effective use of medical devices for the benefit and safety of patients, achieving best value for money.
- Act as the Trust medical devices safety officer (MDSO) ensuring the Trust responds effectively to manufacturer and MHRA device safety notices.
- Lead on the investigation of serious device related incidents or significant near misses to determine root causes, and implementing the necessary changes in procedure, training, or culture to reduce the likelihood of reoccurrence.
- Advise on the requirements of the medical devices regulations for novel medical devices.
Job description
Job responsibilities
Please see the full job description attached.
- To develop and lead the multi-professional Medical Equipment User Support team.
- Be responsible for ensuring safe, appropriate and effective use of medical devices for the benefit and safety of patients, achieving best value for money.
- Act as the Trust medical devices safety officer (MDSO) ensuring the Trust responds effectively to manufacturer and MHRA device safety notices.
- Lead on the investigation of serious device related incidents or significant near misses to determine root causes, and implementing the necessary changes in procedure, training, or culture to reduce the likelihood of reoccurrence.
- Advise on the requirements of the medical devices regulations for novel medical devices.
Person Specification
Qualifications
Essential
- BSc/BEng in a relevant clinical, scientific or engineering subject or equivalent.
- Registration with the Register of Clinical Technologists or HCPC, or eligibility to register within one year.
- Post graduate degree (MSc) or post graduate clinical or scientific experience.
Desirable
- Post Graduate Quality or Management Qualification.
Experience
Essential
- Experience in operation and function of patient-critical equipment and techniques in healthcare.
- Experience in interpreting different situations and judging measures required to ensure appropriate use of technology.
- Experience in electro medical engineering workshop practices and techniques, including preventative maintenance, servicing, inspection, repair, calibration, quality control, safety, acceptance testing and procurement.
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate.
- Experience of medical device incident investigations.
Desirable
- Experience of delivering training programmes to clinical equipment users.
- Experience of the operational management of medical equipment libraries.
- Experience in the use and operation of a quality management system such as ISO 9001
Knowledge
Essential
- Specialist in-depth knowledge of medical device systems through post qualification training and experience.
- Broad knowledge of medical device operation and management.
- High level of understanding of the impact of all aspects of equipment use and provision on clinical service delivery
- A sound knowledge of medical terminology and associated understanding of patient/staff risks arising from medical equipment issues.
- Evidence of Continuing Professional Development.
- Knowledge of relevant legislations, National Standards and MHRA guidelines.
Desirable
- A good understanding of COSHH, ISO9000, Health and Safety.
- Use of equipment and incident/risk management databases.
- Knowledge of employment procedures and practices.
Skills
Essential
- Good planning and prioritisation skills.
- Good analytical, problem solving and interpretive skills.
- Excellent IT skills with ability to manipulate and extract information from databases, create reports etc.
- Effective communication, negotiation and persuasive skills.
- Excellent customer care skills.
- Physical accuracy with good dexterity and manipulation of fine precision tools which demands accuracy and consistency.
- Ability to discern factual information from sources that might include conjecture, speculation and opinion.
- Ability to quickly understand a complex clinical environment or procedure to assist incident investigation
Desirable
- Financial and accounting experience to reconcile invoices and evaluate contracts.
- Experience of audit techniques and action planning.
- Able to communicate complex information across professional boundaries (e.g. incident analysis).
- Able to deliver teaching and training on complex equipment to other professional groups (e.g. train staff in medical device use).
Person Specification
Qualifications
Essential
- BSc/BEng in a relevant clinical, scientific or engineering subject or equivalent.
- Registration with the Register of Clinical Technologists or HCPC, or eligibility to register within one year.
- Post graduate degree (MSc) or post graduate clinical or scientific experience.
Desirable
- Post Graduate Quality or Management Qualification.
Experience
Essential
- Experience in operation and function of patient-critical equipment and techniques in healthcare.
- Experience in interpreting different situations and judging measures required to ensure appropriate use of technology.
- Experience in electro medical engineering workshop practices and techniques, including preventative maintenance, servicing, inspection, repair, calibration, quality control, safety, acceptance testing and procurement.
- Experience of undertaking risk assessments on medical devices and have ability to find novel solutions to minimise risk where appropriate.
- Experience of medical device incident investigations.
Desirable
- Experience of delivering training programmes to clinical equipment users.
- Experience of the operational management of medical equipment libraries.
- Experience in the use and operation of a quality management system such as ISO 9001
Knowledge
Essential
- Specialist in-depth knowledge of medical device systems through post qualification training and experience.
- Broad knowledge of medical device operation and management.
- High level of understanding of the impact of all aspects of equipment use and provision on clinical service delivery
- A sound knowledge of medical terminology and associated understanding of patient/staff risks arising from medical equipment issues.
- Evidence of Continuing Professional Development.
- Knowledge of relevant legislations, National Standards and MHRA guidelines.
Desirable
- A good understanding of COSHH, ISO9000, Health and Safety.
- Use of equipment and incident/risk management databases.
- Knowledge of employment procedures and practices.
Skills
Essential
- Good planning and prioritisation skills.
- Good analytical, problem solving and interpretive skills.
- Excellent IT skills with ability to manipulate and extract information from databases, create reports etc.
- Effective communication, negotiation and persuasive skills.
- Excellent customer care skills.
- Physical accuracy with good dexterity and manipulation of fine precision tools which demands accuracy and consistency.
- Ability to discern factual information from sources that might include conjecture, speculation and opinion.
- Ability to quickly understand a complex clinical environment or procedure to assist incident investigation
Desirable
- Financial and accounting experience to reconcile invoices and evaluate contracts.
- Experience of audit techniques and action planning.
- Able to communicate complex information across professional boundaries (e.g. incident analysis).
- Able to deliver teaching and training on complex equipment to other professional groups (e.g. train staff in medical device use).
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).
