Medical Devices Manager (Electronic & Biomedical Engineering) in Birmingham

Posts & hours: Based at: SSL Hub Hours: 37.5 hours Salary: £49,242.47 - £52,796.67 per annum

At SSL we rely on diversity to deliver on our goals. We actively encourage applications from talented and qualified individuals from all walks of life regardless of race, gender, marital status, national origin, religion, sexual orientation, disability or age.

Disclosure: All roles will be subject to a successful disclosure at an appropriate level from the Disclosure and Barring Service (DBS), satisfactory reference check, qualifications check, occupational health check and mandatory training prior to commencement of employment.

Main duties of the job: The Medical Devices Manager will provide Trust-wide specialist leadership, governance and operational oversight for all medical device-related activities across Birmingham and Solihull Mental Health NHS Foundation Trust (BSMHFT). The postholder will act as the Trust's subject-matter lead for medical device management, ensuring that equipment is selected, used, maintained and disposed of safely and in compliance with legislation, national guidance and Trust policies. All servicing, maintenance and repairs are delivered by a third-party specialist contractor, with this role providing governance, oversight and assurance rather than hands-on engineering. The role includes strategic oversight of the Trust's third-party medical device servicing and repair contractor, ensuring service compliance, performance assurance and best value. The postholder will also manage device lifecycle planning, asset management, IT integration, training assurance, and device safety governance.

About us: At SSL, we work in partnership with Birmingham and Solihull Mental Health Foundation Trust (BSMHFT), to deliver facilities management, transport and other support services to over 50 sites across the West Midlands. Our team keeps expanding and since our establishment in 2012, we have grown rapidly through the acquisition of new sites and services. At SSL we take pride in our focus to support and contribute to the Trust's aim which is to help people get better and challenge the stigma associated with mental illness. We are committed to continuous development of our practices and people and the provision of a fair and friendly work environment for everyone. Sustainability – All staff are expected to support SSL in meeting our 'Green' objectives, being responsible and considerate with regards to all 'resources' used and acting to minimise waste (e.g., products purchased, miles travelled, or power used). SSL is mandated to meet national carbon net zero targets and is being performance managed towards that achievement. Every member of staff wishing to work for SSL is expected to contribute to a greener and more sustainable organisation.

Job responsibilities: Strategy, Governance & Leadership Provide expert engineering and medical device advice on behalf of SSL to BSMHFT clinical and operational teams. Ensure all activities comply with statutory and regulatory requirements including:

• Medicines & Medical Devices Act 2021
• ISO 13485, ISO 14971
• HTMs, relevant HBNs and national standards
• SSL policies, procedures and governance requirements
• MHRA guidance relating to Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD)
• UKCA/CE requirements for software-based and AI-enabled medical devices
• IEC 62304 (medical device software lifecycle)
• IEC 82304-1 (health software safety)
• NHS Digital Technology Assessment Criteria (DTAC), where applicable

Lead the development, implementation, and review of the Trusts Medical Devices Policy. Contribute to and support the BSMHFT Medical Devices Group, Trust Health & Safety Committee, and SSL Operational Health & Safety meetings, providing reports on compliance, risks, incidents, and contract performance. Provide expert input into investigations of device-related incidents, complaints and serious incidents, ensuring learning is captured and embedded.

Person Specification: Qualifications Formal & Vocational Relevant clinical qualification (e.g. Nursing, AHP, Clinical Technologist) or equivalent healthcare experience. Evidence of continuing professional development in medical devices, patient safety or healthcare governance. Degree in Biomedical Engineering, Electronic Engineering or related field (or equivalent experience). Prince 2 Project Management Qualification.

Knowledge & Experience: Substantial experience working in a healthcare environment with responsibility for medical devices or clinical equipment. Experience of medical device governance, safety, policy implementation or compliance. Experience managing or overseeing third-party service providers or contracts. Involvement in equipment procurement, evaluation or standardisation. Experience working across organisational boundaries with clinical, technical and corporate teams. Significant experience in being diplomacy when dealing with people and providing feedback. Experience working with individuals at all levels and across organisations including clinicians/other professionals, senior managers, commissioners, patients, and carers. To have a proactive rather than reactive response to achieving the goals of the project. Highly self-motivated with high internal work standards. Experience of working in a Mental Health or acute hospital environment or NHS Hospital.

Skills and personal Qualities: Strong understanding of clinical risk, patient safety and quality governance. Working knowledge of MHRA requirements, device alerts and NHS medical device guidance. Ability to interpret technical information and translate it into clinical and operational practice. Strong communication, influencing and stakeholder-management skills. Organised, analytical and able to provide clear assurance to senior leaders. Strong understanding of governance frameworks: MHRA, HTMs, ISO standards, SFG20. Excellent contract and performance management skills. Ability to lead projects and drive service improvement across organisational boundaries. Proven leadership ability. Able to concentrate and deal with detailed information. Communication skills. Presentation skills. Report writing. Negotiating and influencing skills. Honest. Open-minded, treats colleagues with dignity and respect. Capacity to work with clinicians and staff at all levels. Exemplary personal standards of conduct and behaviour. Inspires others and leads by example. Full driving license. Robust knowledge of medical devices commonly used within mental health, community and inpatient services.

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.