Manor Loan, Stirling
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 700 employees worldwide. In this role, you will be exposed to a wide range of engineering activities as the company grows and develops. The engineering group is responsible for laboratory equipment, prototype equipment, high volume production equipment, packaging equipment, air handling systems and associated equipment. As well as carrying out equipment projects work, you will also develop, document and implement processes and procedures required within the engineering function including validation master plans and validation protocols.
Role & Responsibilities
- Provide the lead on 2 to 3 medium to large-sized engineering projects from conception and design through to delivery and validation.
- Develop and optimise existing and new equipment approaches whether that be for R&D or Production activities.
- Generate Validation Master Plans and Protocols where necessary.
- Execute validation and other qualification activities.
- Support the implementation, development, and management of the Computerised Maintenance Management System (CMMS).
- Achieve the required degree of competence on all equipment sets (through training and experience).
- Liaise with & manage external contractors and internal customers.
- Carry out troubleshooting activities on production & facilities equipment.
- Identify critical spare parts, establish holdings and maintain stock.
- Adhere to GxP and work within the company QMS
- Identify validation risks and their likely impact (i.e. understand the impact of equipment modifications on validation).
- Maintain and update records & ensure appropriate audit trails exist.
- A degree in Engineering or similar relevant qualifications.
- Relevant technical experience in the medical device (or similarly regulated) industry.
- Experience in a high-volume manufacturing environment and management of equipment through the entire life cycle.
- Ability to correctly identify & resolve equipment issues with the use of a range of aids and techniques e.g. schematics, manuals, validation documentation, CMMS.
- Familiar with SolidWorks or similar CAD packages.
- Computer literate with a good knowledge of MS Office products.
- PC or PLC programming experience.
- Six Sigma Green Belt or Black Belt Qualification.
For further information and to apply for this role, please click APPLY