Medical Device Safety Officer

Job summary

The Clinical Engineering Department at Cardiff and Vale UHB are excited to be the first department of its kind in Wales to be recruiting for a full-time Medical Device Safety Officer (MDSO).

This role will give the successful applicant an excellent opportunity to improve patient safety and join a team who are passionate about effective and safe medical equipment management.

Main duties of the job

Ensuring effective reporting and response to adverse incidents involving medical devices, and that lessons are learnt and shared throughout the organisation.

Performing and leading investigations into a broad range of patient safety incidents involving medical devices.

The post-holder will also play a key role in the management of medical device safety alerts including their assessment, distribution and support for identified safety actions.

Interpreting legislation, national guidance and industry best practice into UHB policy and management processes to ensure national initiatives and required changes are delivered.

Person Specification

Qualifications

Essential

• Degree qualification in relevant subject. (or HNC/HND equivalent with apprenticeship)
• Extensive additional theoretical knowledge acquired through CPD (professional short courses, personal study, conferences) and professional training in relevant working environments.
• Professional registration (eg: Incorporated Engineer; Registered Clinical Technologist, HCPC, etc.).
• Masters level qualification (equivalent experience).

Experience

Essential

• Extensive professional experience of hospital clinical engineering services, with a broad knowledge & experience of medical technology and its applications.
• Extensive specialist knowledge and practical experience in medical engineering workshop services at senior level, with expert understanding of best practices relating to to equipment commissioning, assurance, maintenance, repair, and decommissioning activities.
• Sound knowledge of medical device governance in healthcare environments; knowledge of regulatory framework and auditing standards (CQC, MHRA, HSE, MDR, etc.).
• Considerable experience of medical device incident investigations and safety alert management. Sound knowledge & experience of risk management techniques and their application.

Desirable

• Experience of competency management in practice; experience of mentoring the professional development of technical staff. Sound knowledge, and experience of its application, in the field of quality management systems and relevant standards (eg: ISO-9001, ISO-13485, etc.).
• Auditing experience – capable of planning, conducting and reporting audits.
• Work experience within project & programme environments.

Skills

Essential

• Advanced software user skills; (competent user of office, spreadsheet & database applications, etc.).
• Ability to develop professional rapport with departmental staff, managerial staff, service users and suppliers. Ability to communicate complex information across professional boundaries to a range of staff; ability to receive and process information from a similar range of professions. Ability to deal with complex and unpredictable situations and people; able to deal with difficult situations and customer anxiety in a professional manner. Ability to lead operational and project groups; good meeting management and chairing skills. Good negotiation and influencing skills, able to provide assurance and reports with credibility and integrity.
• Excellent documentation and reporting skills Ability to empathise with, support and guide junior staff and trainees. Ability to objectively investigate incidents and problems without prejudice or preconception, adopting an open and questioning approach with committed attention to detail. Ability to independently prioritise, analyse, and investigate complex service issues and problems; to identify root causes and resolve, ensuring that effective interventions are implemented. Ability to interpret and apply legislation / policy where there is no precedent.
• Ability to collect, analyse and critically interpret complex data sets and to report accordingly. Ability to plan and drive initiatives and programmes of work across the service to optimise safety management, both within own department and to support clinical departments where medical devices are used. Ability to exercise initiative and leadership when working within own area of competence and expertise. Ability to respond positively to changes in priorities and demands; and to work independently and under pressure, optimally prioritising workload.

Desirable

• Ability to deliver teaching and training on medical device safety, risk management & governance to departmental staff and other professional groups. Experience of supporting clinical or scientific research projects.

Closing Date: 9 August 2026