STEM Recruitment Solutions is recruiting on behalf of our client who operate as a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions.
In this role, you will be exposed to a wide range of engineering activities. 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.
* 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.
You will be an experienced equipment engineer who is enthusiastic, self-directed and with a proven track record of delivering on your goals.
Other requirements to be successful in this role are as follows:
* 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.
If this sounds like you, please apply with your CV in the first instance