Senior Technician - Device Testing

My client is a world class medical device consultancy that works with a vast range of clients from start ups to large multinational organisations.

They are currently looking for a Senior Technician to join their Device Testing group, working on a wide variety of medical and drug delivery devices.

You will report to the Device Testing Project Manager and work within internal project teams to provide testing expertise of medical devices.

You will be a key user of Team’s test labs and workshops; and also support the preparation and review of test documents. As an expert in testing, you will present your findings to clients.

Key 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.

·       Support project teams in planning and delivering test work. This could include some supervision of colleagues or contractors where necessary.

·       Produce high quality test data and, interpret and present findings to the project team and client.

·       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.

·       Support change through training and adoption of best practices.

·       Contribute to technical investigations, including non-conformances.

·       Liaise with 3rd party suppliers.

·       Uphold health and safety procedures and guidelines for safe working with hazardous chemicals and pharmaceutical formulations.

Requirements

Qualifications and Skills

Essential

·       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

·       Track record in developing complex or novel testing methodologies

·       Structured and methodical problem-solving approach

·       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

Desirable

·       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

Leadership / Consultancy Skills

Essential

·       Excellent communication and presentation skills to technical and non-technical audiences, including clients

·       Versatility to work diligently and effectively as part of several projects

·       Proactively critically review and challenge the status quo if necessary and provide alternative pathways for debate

Desirable

·       Experience of working in a consulting environment

Personal Qualities

·       Proactive and effective in managing own time, with the ability to work collaboratively as part of a team

·       Conscientious and motivated, with an eagerness to teach and learn

·       Methodical approach to tasks, with an eye for detail

·       Dependable and calm under pressure

·       Determination and dynamism to drive complex issues through to successful conclusion

·       Respectful of others’ views, opinions and contributions

Additional Role Requirements and Working Patterns

·       Onsite work required