Human Factors Engineer - Cambridgeshire
CK Group is recruiting for a Human Factors Engineer to join a company in the medical industry at their site based in Cambridge on a 6 month contract basis.
Our client is one of the largest bio-pharmaceutical companies operating in the UK. They are committed to helping the UK develop the talent it needs to achieve the aspiration of being a global leader in life sciences, from the school classroom to PhDs. They are committed to working with the NHS, academia and other healthcare organisations to improve the delivery of healthcare and achieve the best health outcomes for people in the UK.
The position will be based at our clients Device Centre of Excellence where they specialise in the design and development of drug delivery devices, such as injectors or inhalers. The DCoE group based at Cambridge, UK is responsible for the design of new devices, along with the testing and industrialization.
The Human Factor's Engineer will join the global drug delivery device team who engage in projects across all business units and therapy areas within the companies global network. A core activity within device development is management and execution of Human Factors Engineering activities for drug delivery system projects and compiling of related documentation for product regulatory submissions.
Key duties include:
- To work with the drug product team, external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables including project managing the supply, assembly and testing of materials for use in HF studies.
- To assist in the generation of human factors regulatory documentation associated with medical devices devices.
- To provide support for the assessment and management of suppliers for human factors, and compliance issues related to the use of devices in the hands of users.
- To provide input and support for generation and change control of all company device Instructions for Use (IFU) documentation.
- To provide device usability input/support to device design inputs and HF study feedback and/or recommended mitigation actions into the DCoE design group and external device design authorities.
- To provide input into risk management activities related to assigned projects.
- To provide guidance to personnel on all human factors engineering matters.
To be considered for this role you should have the following skills, knowledge and experience:
- Excellent written English skills.
- Strong ability to develop concise prose suitable for worldwide healthcare regulatory authorities.
- Comfortable working with all levels of the organisation.
- Strong attention to detail.
- Ability to work with multiple projects.
- Ability to understand medical device technical language.
- Capability to adhere to strict deadlines and prioritise work load under pressure.
- Ability to work on own and use initiative where required, or as part of a team.
- Experience with Human Factors Engineering, ideally for combination products with devices.
- Excellent project/time management skills.
- Excellent IT skills essential - PC literate (rather than Macintosh) with good experience with typical Microsoft Office applications including MS PowerPoint.
- Minimum 3 years relevant experience.
- Advanced qualification in Human Factors/Usability or associated faculty (ideal).
- Appreciation for pharmaceutical/medical device regulatory requirements (ideal).
- Background in a medical field (ideal).
For more information or to apply for this position, please contact Natasha on 01246 457739 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45480 in all correspondence.