LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Working within the product assurance group, you will be responsible for the analysis of data and reporting of studies surrounding medical device development and manufacture. You will also play an active role in promoting the best use of statistics and statistical techniques across the organisation.
- Analysis of data, authoring and review of technical reports and validation documents to support development and manufacture of a medical device across various areas including:
o Verification and validation of key product performance measures and characteristics.
o Product stability trials.
o Ensuring clinical trials using the device are appropriately powered and analysis and review of clinical study results.
o Review of historical performance of the device and making recommendations for continuous improvement.
- Development and maintenance of product calibration procedures and release criteria.
- Support technical teams across the business in the planning, design and analysis of experiments to develop and commercialise medical devices.
- Adherence to GxP and relevant regulatory documents.
- Design of studies to relevant standards and guidelines.
- Leading a data-driven approach to developing world-class medical devices.
- Providing coaching and mentoring to people in the use of statistics across the organisation as required.
- Presentation and discussion of data with colleagues and audiences with various technical and non-technical backgrounds.
- Degree level qualification in statistics or mathematics.
- Medical Device / Diagnostic experience.
- Demonstrable experience of application of sampling techniques, regression and design and analysis of experiments in a science or engineering environment.
- In-depth knowledge of at least one statistical software package.
- Ability to communicate well verbally and in writing with people at different levels across the organisation and with different levels of statistical understanding.
- Experience of analysis of clinical trials.
- Previous use of SAS and Minitab.
At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business
Please note, if you wish to submit an application for this role, please consider the following information
This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.
Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.
LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.
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