Process Engineer - Product Support
Alloa OR Glasgow, UK
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
- 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.
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.
For further information and to apply for this role, please click APPLY