At FlexMedical Solutions, we help our customers create a healthier tomorrow by providing contract design, development, and manufacturing services to medical device OEM’s.
We focus on the disposable component of device and have significant expertise with point of care (POC) in vitro diagnostic (IVD) tests. Our in-house capabilities range from screen printing and laser ablation of electrodes for biosensors to final device assembly, including controlled deposition of chemistries.
The company was formed in 2015 and our facility (brand new in 2016) has recently been further expanded to a very high standard and now require a talented and experienced Equipment Engineer. Based in Livingston, central Scotland, we place a strong emphasis on product quality and have invested significantly in our production and test capabilities.
As an experienced project equipment engineer you will bring a wealth of knowledge and hands-on experience into the business. Working for a vibrant, growing organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
You will have a full understanding of what is required when positioning a piece of equipment within a medical device (Point of Care Diagnostics) manufacturing facility. You will be entirely comfortable in all areas of equipment acquisition from URS generation through FAT and final validation.
FMS is an ISO13485 certified company, and all aspects of the role must be executed according to our Quality Management System (QMS).
This is a vendor facing role and the jobholder will have to be comfortable managing high value subcontracts on behalf of both FMS and our clients.
Reporting to the CTO, you will: –
- Work directly with clients and with in-house staff to understand future equipment requirements
- Generate user requirement specifications (URS’s) for both bespoke and off the shelf (OTS) pieces of equipment and/or automation
- Source, evaluate and select suitable equipment vendors in conjunction with quality and supply chain colleagues
- Position purchase orders and/or contracts with selected vendors
- Sub-contract manage equipment vendors throughout build phase, ensuring timely and on budget delivery of asset
- Design and execute factory acceptance tests (FAT) ensuring all requirements are met or variances justified
- Work with equipment maintenance engineer to facilitate smooth arrival and commissioning of equipment
- Work with validation engineer to design and execute IQ/OQ/PQ protocols
- Work with equipment maintenance engineer to identify and position suitable spares for procured equipment
- Provide regular updates for internal and external stakeholders
Essential Technical Skills
You will: –
- Be able to find creative solutions to complex engineering problems
- Understand Design for Manufacture (DFM) methodology
- Have a solid electro-mechanical understanding and be able to interpret schematics
- Have an excellent attention to detail
- Be highly organised and have excellent time management skills
- Be an accomplished negotiator and be able to navigate pressurised situations
- Be experienced with ISO13485 and be familiar with GAMP principles
- Have experience working with printers, lasers, labelling, dispensing, die cutting and lamination type systems
Desirable Technical Skills
It would be beneficial if you: –
- Have competency in the use of 2D/3D CAD software such as Solidworks and AutoCAD
- Are 18th Edition qualified
- Are experienced using statistical tools such as Minitab
- Have knowledge of validation in medical device processes
- Have experience working with visual inspection systems
Knowledge & Experience
- You will likely hold a Batchelors degree in a relevant engineering subject and have at least 7 years experience working in a regulated environment. Alternatively, you will have a minimum of 10 years experience combined with relevant vocational qualifications
- You must be able to work autonomously
- A green or black belt qualification in six sigma / process excellence would be advantageous but is not a pre-requisite.
Environment & Culture
FlexMedical Solutions is dynamic, scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on several leading-edge projects with some very exciting customers.
It is a changing environment that requires you to be very flexible and willing to learn and grow with the company. It is essential that you communicate with your team and contribute to the company’s success. As a provider of sub-contract services, working for FlexMedical Solutions will bring a lot of variety and excitement. Initiative will be rewarded, and personal development is a given.