At FlexMedical Solutions, we help our customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEM’s.
We focus on the disposable component of the medical 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 the formulation and deposition of chemistries.
Our modern facility is based in Livingston, central Scotland, less than 20 minutes from Edinburgh airport and 40 minutes from Glasgow. Further growth means that we are now developing our capabilities in product development. With a mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
As an experienced engineer you will bring hands-on, technical expertise to the company, helping us deliver on our goals and objectives. Working for a vibrant, growing organisation will provide you with a fantastic opportunity to make your mark and implement your ideas. With a strong interest in how products work chemically, mechanically, and electrically you will be confident in creating new manufacturing processes for your newly designed products. Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf) with activities extending from early concept to full scheduled development and manufacture (all under ISO13485 jurisdiction).
You will be responsible for: –
- Designing and developing solutions to complex challenges
- Designing and executing technical feasibility experiments
- Interpreting customer requirements and in turn generating technical specifications and associated documents
- Providing detailed, technically thorough reports and presentation
- Author, oversee and execute protocols
- Communicating effectively with sub-contractors, suppliers & clients
- Develop product and process technical documents to successfully introduce new products into manufacturing, including validation protocols and reports
- Leading work packages and supporting junior members of staff
- Working on several client projects simultaneously
- Ensuring that quality and regulatory procedures are always adhered to
Essential Technical Skills
You will: –
- Be competent in the use of modern manufacturing equipment (e.g. lasers, robotics, liquid dispensing) and metrology equipment (e.g. CMM, contact angle)
- Understand Design for Manufacture (DFM) methodology
- Be competent in the use of 2D/3D/CAD software such as Draftsight & Solidworks and CAM packages such as AlphaCAM
- Be able to perform statistical analysis on data using tools such as Minitab
- Understand current manufacturing methods including rapid prototyping
- Have worked to ISO13485 and 21 CFR Part 820
Desirable Technical Skills
It would be beneficial if you: –
- Have a working knowledge of biosensor design and development
- Are experienced in product and process validation
- Have experience in laser processing, screen printing or surface modification techniques
Knowledge & Experience
- You will hold a degree in a technical / engineering subject and have a minimum of 3 years relevant experience. However, consideration will be given where significant industry experience can be demonstrated in lieu of academic qualifications
- A black belt or green belt qualification in six sigma / process excellence would be most advantageous
- People management experience would be advantageous but is not a pre-requisite
Environment & Culture
FlexMedical Solutions is a young, vibrant organisation operating in a highly regulated industry. 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 guaranteed.