Process Engineer - Product Support
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 600 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
An experienced Process Engineer who can make a significant contribution to the continued growth and success of our company.
As a Process Engineer you will work in close collaboration across science, reagents, pilot line, instrumentation, equipment, process, quality assurance, quality control and suppliers, to develop new and innovative products.
You will also support all aspects of product development such as materials optimisation, fluidics testing, defining Critical To Quality (CTQ) elements, along with providing support to process engineering, manufacturing, quality and equipment engineering as required.
- Product performance monitoring.
- Error tracking, both internal and external, to ensure a proactive response to potential issues.
- Troubleshooting, rapid diagnosis and resolution of product problems using a methodical approach and report progress in a structured way.
- Statistical analysis, trend monitoring and reporting.
- Determine, categorise and develop mitigation for product failure modes.
- Materials selection and optimisation where needed.
- Fluidics testing and assessment as needed.
- Define and improve Critical To Quality (CTQ) elements to drive product performance improvements.
- Drive Design For Manufacture (DFM) into the product designs.
- Investigate, root cause & resolve Non-Conformances / Quality Events.
- Be open to self-development and the development of others during the transition of products from R&D through to volume manufacture.
- Adhere to all relevant regulatory requirements.
- Engage the product owners in the identification of product performance drivers.
You will be highly motivated engineer and have excellent proven experience in continuous improvement in a regulated environment with a strong knowledge of how to use data to help improve performance.
Other requirements to be successful in this role are as follows:
- A hands-on Process Engineer with a high level of relevant industry experience.
- Experience of optimising products, medical would be an advantage.
- Experience / willing to learn the use of metrology equipment to assesses and characterise products and materials.
- 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 and cGLP experience.
- High level of computer literacy in MS Office.
- Competent in documentation and report writing.
- Green Belt or Black Belt certification would be beneficial.
For further information and to apply for this role, please click APPLY.