Senior Design Assurance Engineer

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Currently working with an exceptionally successful, rapidly growing Artificial Intelligence Healthcare focused technology and product organisation who have won numerous awards recognising their rapid growth, technology and for leading in their field since their inception to find a Design Assurance Engineer based in South West London.

The company are at the cutting-edge intersection of traditional healthcare, virtual services and artificial intelligence and require a Design Assurance Engineer to effectively navigate the Regulatory challenges associated with developing and launching stand-alone Medical Device Software and Mobile Apps.

The Design Assurance Engineer will need to have a background as a Software Engineer and fluent in either Python or Java and have expert knowledge of implementing design controls in an Agile environment.

Key Skills & Experience:

* Knowledge of relevant standards including TIR452012, ISO13485, ISO14971, IEC62304, 21 CFR 820

* Experience of Design Controls and Risk Management processes

* Understanding of the MDD and new MDR

* Experience of NHS standards SCCI0129 and SCCI0160 preferred but not essential

* Experience of Software Engineering in an Agile project management environment

* Good understanding of Software Security principles

* Understanding of DevOps principles such as TDD/BDD and CI/CD

* Experience with JIRA and Confluence * Fluent in either Java or Python

* Able to define and implement a secure, quality-focused SDLC

Personal profile:

* Self-starter who has a positive mentality

* Pragmatic problem solver with a meticulous attention to detail

* Genuine passion for changing the healthcare landscape

If you are interested in hearing more about this position please apply below or contact Gavin Johal at Real Staffing.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales