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 OEMs.
We focus on the disposable component of diagnostic devices 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 expanding our premises, capabilities, and systems. With a mixture of UK and international clients, we are a forward-looking organisation with an exciting future.
As a qualified scientist you will bring hands-on, technical expertise to the company.
Having gained experience in the laboratory, you will understand in-vitro diagnostics and may have some specific experience in reagent development and common assay detection methods.
As a contract business, we work on multiple projects simultaneously. This brings a lot of variety and requires people who are both willing and able to develop new products and processes in unison with our design control process. Your time will be spent working on some of our customer specific contracts (developing and producing diagnostic products on their behalf) and working on internal development programmes.
Working for a scale-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
Reporting to the Technical Lead, you will: –
- Build reagents / formulate customer solutions to their requirements.
- Develop and execute electrochemical methods for external customer requirements, and internal development programmes.
- Develop reagent deposition methods, and sensor build processes to ensure rapid, consistent, and precise sensor production for development programmes.
- Manage on-site chemicals / reagents with regards to inventory, H&S, storage, and containment.
- Execute R&D protocols and reports, ensuring compliance with the documentation requirements within the GLP lab.
- Provide scientific input into product and process designs, ensuring optimal performance and client satisfaction.
- Produce characterisation reports for customer products and development reports for internal programmes aligned to FMS design Quality Management System.
- Stay informed of latest developments and trends in your field e.g. current trends and methods in IVD development through routine review of current scientific literature.
Skills, Knowledge and Experience required
- As a minimum, you will hold a degree level qualification in a relevant scientific subject.
- You will have relevant experience gained in a regulated environment.However, consideration will be given where relevant academic experience can be demonstrated in lieu of industry experience.
- Competent using routine laboratory equipment (pH meters, balances, pipettes).
- Experienced in building reagents and formulations from first principles.
- Experienced in electrochemical methods or other IVD detection systems.
- Competent using complex laboratory equipment such as reagent deposition systems and contact angle measurement equipment.
- Able to process raw data and summarise this, communicating findings effectively.
- Understand Good Manufacturing and Good Laboratory Practices requirements (GxP).
- A Green or Black Belt qualification in Six Sigma / process excellence is highly advantageous.
- Competent in the use of modern manufacturing equipment (e.g. lasers, dispensing, lamination & assembly) and metrology equipment such as CMM.
- Experienced in IVD product development, operated under ISO 13485 or 21 CFR Part 820.
- Understand Design for Manufacture (DFM) methodology.
- Experienced using statistical tools such as Minitab, and understand Design of Experiments methods (DoE).
- Experienced in reagent chemistry as applied in IVD products.
- Experienced in surface chemistry: modification and analysis.
Environment & Culture
FlexMedical Solutions is a young and evolving start up organisation, now scaling, and operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of leading edge projects with 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 great deal of variety and excitement; initiative will be rewarded and personal development is a given.