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 500 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
- Product and process performance monitoring.
- Troubleshooting, rapid diagnosis and resolution of problems in existing manufacturing plant & processes, using a methodical approach and report progress in a structured way.
- Statistical analysis, trend monitoring and reporting.
- Determine, categorise and develop mitigation for failure modes.
- Develop & improve manufacturing methods utilising knowledge of product design, materials, fabrication processes, tooling and production equipment assembly methods.
- Investigate root cause and resolve Non-Conformances / Quality Events.
- Be open to self-development and the development of others during the transition from R&D through to volume manufacture.
- Adhere to all relevant regulatory requirements.
- Engage the production team in the identification of cost and inventory reduction initiatives, whilst also striving to streamline workflow.
- A hands-on Process Engineer with a high level of relevant industry experience.
- Experience of optimising product and processes in the medical industry would be an advantage.
- Knowledge of statistical process controls, capabilities and analysis techniques.
- Experience of executing GRR (gage repeatability and reproducibility) protocols .
- Experience of executing product and process verification protocols.
- Experience of Design of Experiments.
- cGMP experience.
- High level of computer literacy in MS Office.
- Competent in documentation and report writing.