Band 8c - Medical Devices Manager

Job responsibilities

• Appraisal and audit of both new and existing service contracts, ensuring that all medical devices have quality maintenance cover where required
• Develop and maintain compliance with the ISO 9001:2000 quality system
• Produce management reports as requested which may require skills in negotiation and diplomacy where outcomes are contentious, both internal and external to the Trust
• Advising and assisting with Governance issues related to medical devices, including the CQC requirements ensuring the Trust remains Compliant with those requirements
• Preparing reports to all Patient Safety and Governance Committee in conjunction with the Head of Compliance
• Fulfil the role of Medical Devices Safety Officer as required by MHRA
• Carry out evaluation of Capital Bids for medical devices.
• Advise on the evaluation, trailing and subsequent procurement of proposed new equipment purchases.
• To ensure that no capital purchase is made of Medical Devices in the Trust without going through the agreed process of scrutinisation in order to ensure compliance with Trust policies, standing orders and standing financial instructions.
• To manage and maintain a database of capital medical equipment and to extrapolate a replacement plan to enable improved financial business planning and produce regular reports to the Capital Finance Planning Group and Medical Devices Committee.
• To manage and maintain a Trust wide medical equipment loan library to enhance patient care and maximise return on resources
• To lead projects relating to clinical/equipment issues to positively drive improvement and innovation to providing continued management support to the Directorate and Trust.
• To be the Head of Service and Line Manager for all members of the Medical Device Management Services staff and to ensure that all individuals within the service are aware of their clinical governance and Health and Safety responsibilities and work within all Trust policies.
• To be the Trusts specialist in developing Medical Devices Management in line with National Guidelines on Standards for Better Health and CNST requirements through strategy and policy development and implementation for the Trust.
• To develop, implement and review Trust wide policies and procedures to ensure good performance of Medical Devices.
• To lead the clinical aspects in the involvement and establishment of contracts with other users of Medical Devices through the tendering procedures and equipment evaluation program.
• To provide relevant training courses for all levels of clinical and nursing staff involved with Medical Devices. To include devising and communicating materials used to convey complex information to large groups of users which may impact on service delivery.
• Line manage Clinical Engineering staff
• Perform staff appraisals, interviews and the selection and recruitment of staff
• Agree own work plan with Services Directors, in line with a 5 year strategic plan
• Develop and publicise own progress reports to keep the Trust informed of progress of work plans. These reports may be highly complex and at time sensitive and/or contentious. The quality of the reports is to be at Trust Board level;
• Periodically realign work plan(s) in line with clinical services developments
• Develop and imbed Trust policy and procedures around the type, maintenance, user training and competency and decontamination of all medical devices ensuring compliance with current national and International guidelines
• Rationalise the equipment inventory to enforce standardisation and removing redundant items
• Be responsible for the authorisation process of all medical devices /equipment, ensuring device/equipment needs are valid prior to purchase;Monitoring the Medicines and Healthcare products Regulatory Agency (MHRA) Alerts;Implement and monitor alerts from the DoH Central Alert System (CAS);
• Lead on operational projects involving medical equipment

Person Specification

Education

Essential

• Master's degree or equivalent experience or degree equivalent with highly developed specialist knowledge of medical device management Evidence of continuing professional development State
• Registered Clinical Scientist Chartered Status Corporate member of the Institute of Physics and Engineering in Medicine

Desirable

• State Registered Clinical Scientist Chartered Status Corporate member of the Institute of Physics and Engineering in Medicine

Knowledge

Essential

• Knowledge and experience of clinical engineering
• Specific knowledge of the broad range of medical devices in use in an acute trust
• Knowledge and experience of the development and management of contracts
• Management and technical expertise required to fulfil the MDSO role

Desirable

• Trained in Audit
• Knowledge of the E-Quip medical devices asset database
• Trained in risk management, ideally using the DATIX system

Experience

Essential

• Significant experience of medical device management at a senior level within an NHS acute hospital setting
• Experience and ability to successfully develop and monitor budgets for a department. Ability to prepare plans for activity and financial aspects of service provisions, contributing to overall strategy.
• Experience of contributing to strategic agendas, both setting objectives in line with government./ MHRA policy and directives.
• Experience of management and leadership- ability to make decisions and through leadership influence others to carry them out to affect change.
• Experience of the planning and organisation of activities and programmes that support change and drive improvement. ...