Job summary
This role represents a unique opportunity to work within the Clinical Engineering Innovation (CEI) team at Cambridge University Hospitals NHS Foundation Trust (part of the Medical Physics and Clinical Engineering department).
CEI is a small, dynamic in-house team of design engineers and clinical scientists who work with clinical innovators to develop novel medical technologies, primarily medical devices.
The post will be focused on the entire regulatory lifecycle of a broad range of medical devices and technologies, encompassing strategy, design, development, verification, validation, clinical evaluation, certification and post-market surveillance activities.
Main duties of the job
CEI are fortunate to work at all stages of the design & development pathway. Being embedded within CUH provides us with a high level of access to clinicians, clinical researchers and patients. We have developed close links with academics from the University of Cambridge and other universities, as well as a wide range of clinical entrepreneurs, start-ups and local consultancies. The team works dynamically to meet the needs of individual projects, with every day bringing with it new and exciting challenges.
Working as part of a team of scientists, designers, engineers and technical staff, you will guide the team in crafting compliant technical documentation, formulate and implement regulatory strategies, manage project submissions, and contribute to the department's Quality Management System. Additionally, you'll leverage your expertise to advise researchers on navigating the regulatory landscape for their medical device studies. You will also have the opportunity to scale up CEI's regulatory services, thereby streamlining our regulatory affairs support for the local innovation ecosystem.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 13,000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 15th September 2024
Interviews are due to commence on the 24th September 2024
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
Due to Home Office immigration rules, a full time permanent vacancy cannot be filled by individuals on a Student visa. Therefore, please be advised that if you are a Student visa holder, we will not be able to offer you a full time permanent contract unless you have:- applied for a Graduate visa- or you will have successfully completed your course and have applied for a Graduate visa before the anticipated start date of your employment- or the Trust has agreed that they will Sponsor you as a Skilled Worker and you will complete your studies within 3 months of the anticipated start date of employment
This vacancy will close at midnight on 15th September 2024
Interviews are due to commence on the 24th September 2024
Benefits to you
At Cambridge University Hospitals, we want to do all we can to support good working days. We offer development opportunities and a wide range of benefits, including on-site leisure facilities, shopping concourse and day nurseries. Our good work programme currently includes providing reduced cost Stagecoach bus travel to and from Cambridge University Hospital site. Park and Ride bus journeys between Babraham Road and Trumpington sites are free, as is the route to and from Cambridge train station and our hospitals. We also subsidise the cost of parking on site for eligible staff.
On CUH campus, hot food is available 24/7 and at a reduced cost for colleagues. Recently we launched the first of our staff pod break spaces. Located in the Deakin Centre, we have a purpose-created colleague-only caf, with free tea and coffee, a break space and private outside area for colleagues to rest, refuel and recharge. Just one of the ways we are working hard to support good working days at CUH.
CUH is committed to assisting employees in achieving a good work-life balance irrespective of role or personal circumstances. Flexible arrangements may include, but are not limited to, part-time working, job-share, term-time working and flexible start and finish times.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Honours degree or equivalent in an appropriate scientific, engineering, or relevant field (at the equivalent of a 2:2 or above).
- Postgraduate degree (e.g. Master's level or above) or equivalent in an appropriate scientific, engineering or relevant field
Desirable
- State Registered Clinical Scientist
- Membership of relevant professional institution
Experience
Essential
- Experience of risk management and related product risk assessment processes
- Experience of working with a document management system
- Experience carrying out research - collecting, recording and analysing data
- Experience of document production processes
- Practical experience working on projects related to Medical Devices
- Experience in the innovative use of technology in healthcare
- Communicating effectively with a wide and varied audience, including delivering training
Desirable
- Experience of creating and maintaining technical documentation in compliance with medical device regulatory frameworks
- Experience of medical device risk assessment and risk management processes - experience with ISO 14971 preferred
- Experience carrying out post-market surveillance activities
- Experience working as part of a multidisciplinary team
- Experience relating design activities to regulatory needs and commercial goals
- Experience in early stage design and development
- Experience with standards management software, such as BSI Compliance Navigator
Knowledge
Essential
- Knowledge of quality management systems
- Awareness of the regulatory requirements around medical device development including UKCA and CE marking of medical devices.
- Knowledge of relevant legislation, national standards, professional and other guidelines [e.g. ISO 9001, BS EN 13485, BS 14971, BS EN 62366, IEC 62304, ISO 60601 series standards and other relevant BSI standards, RIDDOR, MHRA guidance, Health and Safety, COSHH]
- Good understanding of research methodologies from several disparate disciplines
Desirable
- Detailed knowledge of the regulatory requirements for UKCA and CE marking of medical devices including the Technical File and Risk Management requirements.
- Knowledge of the role and significance of intellectual property on the design and development process in Healthcare.
- An understanding of the IRAS system and research governance as it relates to medical device studies
- Understanding of the Health Institution Exemption (HIE) process
- Knowledge of Essential Requirements for medical devices
- Working knowledge of technical skills used in development of medical devices and technologies (such as software development, electronic engineering, design skills, usability engineering)
Skills
Essential
- Excellent analytical skills and attention to detail when reviewing relevant standards regulations and guidance, especially where there is complexity and ambiguity in their application
- Compelling and articulate communicator of complex and sometimes conflicting concepts and requirements to both lay people and experts (including to multidisciplinary colleagues)
- Excellent interpersonal skills: able to negotiate with and relate to a wide range of people, in order to accommodate competing or conflicting requirements of multiple stakeholders, to comply with current regulatory requirements and standards
- Able to prioritise and manage own work and demonstrate excellent organisational skills in project management, including regulatory submissions.
- Able to plan, manage and deliver projects within allocated budget and time frame
- Able to exercise own initiative when dealing with complex issues within own highly specialist area of competence
- Finance acumen, with the ability analyse financial data and identify revenue-generating opportunities.
Desirable
- Attention to detail with regards to creating documentation
- Ability to design document templates that are self-explanatory and easy to use by others
- Good skills in negotiation and persuasion
- Ability to persuade senior clients (e.g. executive level members of the Trust, or world-leading academics) on potential contentious matters
- Capable of creative and innovative thinking
- Strong problem solving skills
- Experience in the formulating plan and coordinating on the delivery of complex, multiphase projects
Additional Requirements
Essential
- Willing to be flexible in working practices
- Improvement mindset - able to identify flaws in our internal Quality Management processes, prioritise, and lead/complete improvement actions
- Enthusiasm and commitment to learn new skills
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
Desirable
- Able to deal with occasional distressing topics
Person Specification
Qualifications
Essential
- Honours degree or equivalent in an appropriate scientific, engineering, or relevant field (at the equivalent of a 2:2 or above).
- Postgraduate degree (e.g. Master's level or above) or equivalent in an appropriate scientific, engineering or relevant field
Desirable
- State Registered Clinical Scientist
- Membership of relevant professional institution
Experience
Essential
- Experience of risk management and related product risk assessment processes
- Experience of working with a document management system
- Experience carrying out research - collecting, recording and analysing data
- Experience of document production processes
- Practical experience working on projects related to Medical Devices
- Experience in the innovative use of technology in healthcare
- Communicating effectively with a wide and varied audience, including delivering training
Desirable
- Experience of creating and maintaining technical documentation in compliance with medical device regulatory frameworks
- Experience of medical device risk assessment and risk management processes - experience with ISO 14971 preferred
- Experience carrying out post-market surveillance activities
- Experience working as part of a multidisciplinary team
- Experience relating design activities to regulatory needs and commercial goals
- Experience in early stage design and development
- Experience with standards management software, such as BSI Compliance Navigator
Knowledge
Essential
- Knowledge of quality management systems
- Awareness of the regulatory requirements around medical device development including UKCA and CE marking of medical devices.
- Knowledge of relevant legislation, national standards, professional and other guidelines [e.g. ISO 9001, BS EN 13485, BS 14971, BS EN 62366, IEC 62304, ISO 60601 series standards and other relevant BSI standards, RIDDOR, MHRA guidance, Health and Safety, COSHH]
- Good understanding of research methodologies from several disparate disciplines
Desirable
- Detailed knowledge of the regulatory requirements for UKCA and CE marking of medical devices including the Technical File and Risk Management requirements.
- Knowledge of the role and significance of intellectual property on the design and development process in Healthcare.
- An understanding of the IRAS system and research governance as it relates to medical device studies
- Understanding of the Health Institution Exemption (HIE) process
- Knowledge of Essential Requirements for medical devices
- Working knowledge of technical skills used in development of medical devices and technologies (such as software development, electronic engineering, design skills, usability engineering)
Skills
Essential
- Excellent analytical skills and attention to detail when reviewing relevant standards regulations and guidance, especially where there is complexity and ambiguity in their application
- Compelling and articulate communicator of complex and sometimes conflicting concepts and requirements to both lay people and experts (including to multidisciplinary colleagues)
- Excellent interpersonal skills: able to negotiate with and relate to a wide range of people, in order to accommodate competing or conflicting requirements of multiple stakeholders, to comply with current regulatory requirements and standards
- Able to prioritise and manage own work and demonstrate excellent organisational skills in project management, including regulatory submissions.
- Able to plan, manage and deliver projects within allocated budget and time frame
- Able to exercise own initiative when dealing with complex issues within own highly specialist area of competence
- Finance acumen, with the ability analyse financial data and identify revenue-generating opportunities.
Desirable
- Attention to detail with regards to creating documentation
- Ability to design document templates that are self-explanatory and easy to use by others
- Good skills in negotiation and persuasion
- Ability to persuade senior clients (e.g. executive level members of the Trust, or world-leading academics) on potential contentious matters
- Capable of creative and innovative thinking
- Strong problem solving skills
- Experience in the formulating plan and coordinating on the delivery of complex, multiphase projects
Additional Requirements
Essential
- Willing to be flexible in working practices
- Improvement mindset - able to identify flaws in our internal Quality Management processes, prioritise, and lead/complete improvement actions
- Enthusiasm and commitment to learn new skills
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
Desirable
- Able to deal with occasional distressing topics
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).
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).