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 currently has over 450 employees worldwide. 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:
- Verification and validation of key product performance measures and characteristics.
- Product stability trials.
- Ensuring clinical trials using the device are appropriately powered and analysis and review of clinical study results.
- 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 device
- 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.
- Experience of working in ideally the Medical Device Sector but would consider individuals with a strong Pharmaceutical background.
- 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.
- Medical Device experience.
- Experience of analysis of clinical trials.
- Previous use of SAS and Minitab.
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