Company Overview
At FlexMedical Solutions (FMS), 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. Our main focus is on Point of Care (POC) in vitro diagnostic (IVD) tests.
We focus on the disposable component of the 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.
Established in 2015, we have continued to expand our facility to a very high standard and have successfully helped several of our clients design, develop and commercialise their products. We are now entering the next phase of our growth, as we embark on volume production.
Role Description
As a qualified scientist you will bring hands-on, technical expertise to the company. Having gained experience in the laboratory, you may have an understanding of in-vitro diagnostics and may have some specific experience in electrochemical and other common assay detection methods. You will have an interest in how products work chemically, mechanically, and electrically.
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 manufacturing diagnostic products on their behalf) and working on internal development programmes.
Working for a start-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
Key Responsibilities
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
- Authoring, overseeing and executing protocols
- Communicating effectively with sub-contractors, suppliers and clients
- Developing product and process technical documents to successfully introduce new products into manufacturing, including validation protocols and reports
- Leading work packages and supporting less experienced colleagues
- Effective management of several client projects simultaneously
Skills, Knowledge and Experience required
Essential
Reporting to the Technical Lead or R&D Senior Scientist, you will: –
- Build reagents / formulate customer solutions to their requirements
- Execute electrochemical methods for external customer requirements, and internal development programmes
- Perform tasks on FMS dispensing systems to accurately deposit solutions and perform subsequent gravimetric analysis
- Manage all on-site chemicals / reagents with regards to inventory, H&S, storage, and containment
- Execute protocols and summarise the outcome in formal reports
- Execute and report lab experiments in support of external client projects and internal development programmes
- Document project work in a compliant manner and in line with the FMS quality management system
- Provide scientific input into product and process designs ensuring optimal performance and client satisfaction
- Initiate non-conformance reports as and when required
- Support routine product manufacturing where required.
Desirable
- Experience in a regulated environment (such as IVD)
- Competent in the use of modern manufacturing equipment (e.g. lasers, dispensing, lamination assembly) and metrology equipment such as CMM
- Competent in the use of 2D/3D CAD software such as Solidworks and AutoCad
- Understand Design for Manufacture (DFM ) methodology
- Experienced in IVD products and their development
- Experienced in electrochemical methods and other IVD detection systems such as fluorescence. chemiluminescence, optical lateral flow devices
- Experienced using statistical tools such as Minitab
- Understands Design of Experiments methods
- A Green or Black Belt qualification in six sigma /process excellence
Environment & Culture
FlexMedical Solutions is a young, evolving and scaling organisation operating in a highly regulated industry. The company is enjoying growth through success and is working on a number of 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 great deal of variety and excitement. Initiative will be rewarded and personal development is a given.