Competitive salary - Cambridge (South), Cambridgeshire, Essex, Saffron Walden - Full Time, Permanent
Our client, based near Saffron Walden, is looking for a Senior Technician to join their Device Testing group.
Working onsite, the role reports to the Device Testing Project Manager and works within internal project teams to provide testing expertise of medical devices. A key user of test labs and workshops; the role also supports the preparation and review of test documents. The Senior Technician will be an expert in testing and will present findings to clients.
Duties & Responsibilities
- Test method development and functional testing at all stages of the development process, from early concept through to verification. This typically includes physical and environmental stress conditioning, detailed inspections, physical dimensional measurements, force and torque testing.
- To support project teams in planning and delivering test work. This could include some supervision of colleagues or contractors where necessary.
- To produce high quality test data, and interpret and present findings to the project team and client.
- To prepare technical documentation in accordance with project requirements, e.g. test methods, test protocols and reports with reference to all appropriate medical device regulations and standards.
- To contribute to technical investigations, including non-conformances.
- Liaising with 3rd party suppliers.
- Upholding health and safety procedures and guidelines for safe working with hazardous chemicals and pharmaceutical formulations.
It is essential for candidates to have the following:
- Extensive experience in authoring detailed protocols and performing high quality test work
- Experience of working in a medical or drug delivery device testing programme
- Knowledge of test methodologies for functions of medical or drug delivery devices
- Proficiency in the use of data analysis tools and statistical analysis
- A track record in developing complex or novel testing methodologies
- A structured and methodical problem-solving approach
- A detailed understanding of ISO standards and industry guidance for medical devices testing
- Working knowledge of quality management systems, including cGxP and ALCOA principles of data management and integrity
- A relevant degree or equivalent experience
- A working knowledge of test method and equipment / verification, validation (e.g. techniques and best practices for Gauge R&R, IQ/OQ/PQ, FAT, SAT)
- Experience using Minitab statistical software
- Excellent communication and presentation skills to technical and non-technical audiences, including clients
- Versatility to work diligently and effectively as part of several projects
- Experience of working in a consulting environment
Due to the rural location, you would need to have your own transport.
Please use this form to apply.