|Job Ref:||204775991||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||County/State:||Oxfordshire||City:||Oxford||Address:||Post Code:||OX4||Post Date:||12/10/2016 03:56|
Project Engineer, Oxford|
Our client is a well-funded start-up medical devices company with patented medical device technology.
This is a unique opportunity to join our client's organisation at an early stage.
This is a role that will suit someone who is happy working in a fast moving environment where your duties will evolve and where you will have room to grow.
You will need to be someone who can work effectively and accurately as the role involves responsibility for helping to build quality management systems for medical devices.
Over the coming years you will be working in pre-clinical and clinical trials to get the necessary medical device approvals.
Our client is ideally looking for an experienced engineer with around 5 years' experience in medical device project management. They will also consider well motivated junior engineers who can prove their willingness and aptitude for the job.
Your role will be very varied and will include:
* Project management
* Develop and manage relationships with suppliers of products and services
* Provide technical support to suppliers
* Provide technical support to Quality (e.g. training, input into non-conformance investigations, customer complaints, etc.)
* Provide support required to generate submissions to regulatory authorities
* Develop design inputs in coordination with the development team
* Work with suppliers to ensure design intent is correctly translated into final product
* Participate in risk management process
* Source and select suppliers of components and services
* Create Test Protocols, Study Protocols and Reports
* Perform design verification and validation to ensure that the product meets all its requirements
* Design test equipment
* Work within medical device quality system in accordance with EN ISO 13485:2016 and 21 CFR 820