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 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 controlled deposition of chemistries. The company was formed in 2015 and our facility has continued to expand to a very high standard.
Based in Livingston, central Scotland, we place a strong emphasis on product quality and have invested significantly in our production and test capabilities and are now developing our scientific muscle in product development.
As an experienced scientist you will bring hands-on, technical, and strategic expertise to the company. Having demonstrated significant skill in the lab through multiple programs, you will be skilled in the development of in-vitro diagnostics and will have specific experience in reagent development for common assay detection methods (such as e-chem, fluorescence, chemiluminescence). As a contract business, we work on manifold projects with several clients simultaneously. This brings a lot of variety and requires people who are both willing and able to work on multiple projects simultaneously.
Working for a scale-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas, helping to steer the company’s technical direction. Your time will be spent working on customer specific contracts (developing and producing diagnostic products on their behalf), and internal development activity.
Reporting to the CSO, you will: –
- Manage significant and discrete bodies of work within projects, major and minor
- Design and build reagents necessary to facilitate biochemical reactions as part of an IVD development
- Develop and execute electrochemical testing experiments, aligned to the needs of the clients’ programs
- Translate wet chemistry design and performance to dry chemistry formats to ensure retention of performance and reliability of a low cost biosensors for a range of sample types
- Write and execute R&D protocols and where necessary verification protocols
- Execute and report lab experiments in support of external client projects and internal development programmes
- Provide scientific input into product and process designs ensuring optimal performance and client satisfaction
- Supervise and mentor less experienced members of the technical team, ensuring their work is of acceptable quality and aligned to projects’ critical paths
- Lead by example in the lab technically and non-technically, ensuring company values are upheld within the teams.
- Provide reports to internal and external stakeholders
- Independently and rapidly root cause, and robustly resolve technical challenges within projects
- Transfer technical design and process into routine manufacturing
- Produce characterization reports for customer products and development reports for internal programmes aligned to FMS’s Quality Management System
- Stay informed with regards to current trends and methods in IVD development through routine review of current scientific literature
Knowledge, Skills, and Experience
Essential Technical Skills
- Be experienced in designing and building biochemical reagents and formulations from first principles
- Have experience in electrochemical methods or other complex IVD detection architectures
- Have experience in IVD product development in a commercial setting
- Be competent using complex laboratory equipment such as Spectrophotometers, potentiostats, and HPLC/FPLC
- Be able to process raw data and summarize findings effectively and communicate future lines of experimentation
- Understand Good Manufacturing and Good Laboratory Practices requirements (GxP)
- Be experienced with ISO13485 and/or 21 CFR Part 820 and familiar with design control and product & process validation
- Be experienced in planning complex bodies of work and communicating and tracking to plan
Desirable Technical Skills
It would be beneficial if you:–
- Have competency in the use of modern manufacturing equipment e.g. lasers, dispensing, lamination & assembly
- Understand Design for Manufacture (DFM) methodology and have experience in implementation
- Are experienced in using statistical tools such as Minitab and understand Design of Experiments methods (DoE)
- Have experience in optimization of screen printed electrodes for biosensor applications
- Have experience in surface chemistry: modification and analysis
- Have experience working with microfluidic devices
- Are knowledgeable in IVD product verification and validation
Knowledge & Experience
- You will have proven, demonstrable experience in a similar role within a regulated environment. Consideration will be given where relevant academic experience can be demonstrated in lieu of industry experience
- You will hold a degree in a relevant scientific subject as a minimum
- A green or black belt qualification in six sigma / process excellence would be advantageous but is not a pre-requisite
- People management experience would be advantageous but is not a pre-requisite
Environment & Culture
FlexMedical Solutions is an evolving, 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 colleagues 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.