Work Flexibility : Not available
Provide support for pre-clinical clinical and usability testing activities within the clinical dept. The team member will provide support in document management data management and analysis. The team member will also support other functions such as regulatory quality and post-market clinical follow up data management of clinical and pre-clinical data including the creation of data management in execution of pre-clinical data processing in data recording during usability and pre-clinical with engineering documentation for clinical regulatory submissions and in initial Bench / Pilot testing and writing or review of technical reports in planning pre-clinical and usability studies including equipment sourcing and preparation of data recording with the training officer and assisting in the training of industrial placement students; in the preparation and organisation of stakeholder and advisory and updating documentation in accordance with ISO 13485 GLP and ISO 14155
Qualifications
* Relevant on-going degree course with acceptable 1st year results
* Relevant A-levels of equivalent
Specific Knowledge
* Knowledge and understanding of cardiovascular anatomy and physiology
* Knowledge of medical devices particularly cardiovascular
* Knowledge or experience of general electronics hardware would be useful
System / Computer Requirements
* Basic Microsoft Office MS Project Adobe Acrobat
* Ability to utilise publication search
Competencies needed for this position
* Excellent communication skills (both written and verbal)
* Problem solving and analytical skills
* Technical writing skills
* Time management skills
* High standard of work and strong attention to detail
* Good teamwork skills and ability to work as part of a multi-disciplinary team
* Ability to work under pressure against tight deadlines
* Demonstrate initiative
Travel Percentage : None
Employment Type : Full-Time
Experience : years
Vacancy : 1
Key Skills
* Laboratory Experience
* Vendor Management
* Design Controls
* C / C++
* FDA Regulations
* Intellectual Property Law
* ISO 13485
* Research Experience
* SolidWorks
* Research & Development
* Internet Of Things
* Product Development
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