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
A Development Engineer who can make a significant contribution to the continued growth and success of our company. As part of the Engineering Group, the Development Engineer will be fully embedded into the Molecular assay team to provide complete support in developing and manufacturing these uniquely complex and technical products.
As a Development Engineer you will cover all aspects of the current R&D assembly process, familiarise yourself and support the high speed manufacturing process, carry out device testing & optimisation; developing test methods, driving continuous improvement and crucially identifying which aspects of the product and process influence final device performance. Moving forward, you will be heavily involved in the scaling up of the R&D process to a high-volume automated production line. As a Development Engineer you will be able to manage a couple of projects concurrently.
- Characterisation of product and process
- Device testing, identifying which aspects of device function are correct and which require optimisation
- Develop robust test methods using Design of Experiments and Statistical analysis
- Determine, categorise and develop mitigation for failure modes
- Define critical design inputs to product and process designs
- Develop & improve manufacturing methods utilising knowledge of product design, materials, fabrication processes, tooling and production equipment assembly methods
- Use a methodical approach to all problem solving and report progress in a structured way
- Perform all processes in accordance with Corporate and Local QMS
- Support the Quality Team with the preparation, review and continued development of QMS procedures and work instructions as appropriate
- Support the company ISO 13485 accreditation
- A hands-on Development Engineer with a level of relevant industry experience in a regulated manufacturing environment working to recognised quality standard(s)
- Experience of device/product development cycle
- Ability to take device ideas from concept through to prototype assembly and performance evaluation
- Knowledge of Design of Experiments
- Experience of developing product specifications and test method validation
- Knowledge of statistical analysis and controls techniques
- Ability to manage external supplier/technical partners
- Able to use Solidworks, AutoCAD or other relevant drawing packages
- Competent in documentation and report writing
- Preferably Degree qualified
- Process Excellence Green Belt or Black Belt
- Experience of characterising and optimising product and processes, in a medical device industry would be an advantage
- Expert of Design of Experiment
- Expert in statistical analysis and controls techniques
- Able to scout and introduce new innovative solutions
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 an comply with the Company information security policies, procedures and guidance.
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