Software Validation Engineer
- Experience Level
- Experienced (non-manager)
This is your opportunity to use your skills and expertise in assuring the development of software and firmware solutions meets appropriate standards to support the delivery of our smart inhalation devices. This role will provide you with an exciting opportunity to work alongside industry experts and have a positive impact on patients’ lives from around the world.
We’re seeking an experienced software engineer to play a critical role in ensuring our medical devices fulfil all requirements before entering the manufacturing phase. Your key responsibility will be to verify and validate the testing of medical devices within the CE marking process.
Other key responsibilities will include (but not limited to):
- Creation of software verification and validation plans and protocols based on specifications and experience in clinical trials and standard applications
- Implementation and executing of device verification and validation, test reporting
- Implementation and executing of software validation
- Organisation and consulting of internal tests or tests with external service providers
- Disclosure of software test results to the developers and the regulatory affairs managers
- Reporting of software errors/bugs for approved devices
What you need
You’ll have a proven software engineering background with a degree in computer science, engineering or related disciplines and a genuine interest in telemedicine and mechatronics disease management.
You’ll be able to demonstrate experience in software verification testing and validation of medical devices to the following standards:
- Standard EN 14971 risk management
- Standard IEC 62304:2015: Medical Devices
- Standards relating to electrical safety EN 60601
- Standards for the regulation of medical devices software
- Standards for the regulation of requirements for inhaler systems (nebulizer inhaler)
You’ll possess experience in compliance within different methods like waterfall-, Iterative- and agile software development method. Demonstrate expertise in ALM Software, Bug Tracking Tool, SW Versioning System, Built Tool, Unit Test Tool and Static Code Analyse.
You’ll be an excellent communicator and proven reliable to execute accurate work with an excellent understanding of technologies and transfer to production.
What you get
Our workplace culture encourages a diverse and inclusive work force. We offer flexible working opportunities that promote a healthy work life balance. We nurture our people through vocational & leadership development, mentoring programmes and career development.
In return for your skills and expertise, we offer a competitive base salary, annual bonus and generous benefits package including a pension plan, life assurance, private health, dental plan, share save/incentive schemes, cycle to work scheme and free parking.
We are global leaders in the development of innovative formulations and devices for inhaled medical products and our specialist technologies helped over seven million patients in 2017. Working collaboratively, we combine technical, engineering, clinical and regulatory expertise to design, develop, industrialise and deliver a unique range of innovative products, from smart nebuliser technologies to innovative formulations.
With a healthy pipeline of new products in development, as well as partnerships with major international pharma companies, it an exciting time to join, You will find it’s an ideal place to develop a stimulating and rewarding career.
To find out more about the role, Vectura and to apply online, click on the Apply button. Closing date for application 01/03/2019
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