Senior Engineer – Design Assurance
With more than 20 years’ experience, this organisation have positioned themselves as true industry leaders in bringing inhaled medicines to market. Their customers choose them for their unique combination of inhalation development expertise, formulation science and device technology.
As a Lead or Senior Engineer, you’ll find a range of challenging, in-depth, technical projects that give you the chance to contribute at every stage of the device development process. Each product brings its own challenges, which gives you the opportunity to hone your skills in a variety of areas, including looking at the human element – how patients use their devices.
You will be taking the lead on validation and verification activities for your projects but you will also be involved in developing requirements as well.
Throughout the project, you will manage project documentation and Design File History.
You will also be developing test plans for your projects. These can range from simple mechanical tests, through to airflow tests and biocompatibility.
Naturally, you will be working closely with partners and colleagues to ensure requirements are met and communicating updates during team meetings and design reviews. Alongside that, you’ll be responsible for:
Planning, implementation, and documentation of the product verification and validation:
Creation of verification and validation plans and protocols based on specifications and experience in clinical trials and standard applications
Implementation of device verification and validation, test reporting
Implementation of software validation
Assistance in the choice of materials for the development and production of inhalation devices
Organisation and consulting of internal tests or tests with external service providers
You’ll have a strong working knowledge of verification and validation of medical devices and the background development processes.
You will need a good level of experience in working to international standards and guidance relevant to medical devices e.g. ISO13485 and 21 CFR Part 820.
An understanding of aerosol therapy for respiratory diseases would be great but is not essential.
Overall, this is a role with lots of variety, where you can make a meaningful impact on products that sustain lives. The diversity of the role means you will be learning and growing continuously, in a company that supports and recognises its people.
If this sounds like you, apply today!