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 OEM’s.
We focus on the disposable component of diagnostic tests and have significant expertise with point of care (POC) in vitro diagnostics (IVD). We can provide full assay development services and have impressive in-house manufacturing capabilities, ranging from screen printing and laser ablation of electrodes for biosensors to final device assembly, including the formulation and deposition of chemistries.
Our modern facilities are based in Livingston, central Scotland, less than 20 minutes from Edinburgh and 40 minutes from Glasgow. Further growth means that we are now expanding our operations capabilities and have a requirement for a talented and experienced Manufacturing Engineer. With a healthy 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 our 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 a focus on transferring products from development to operations (all under ISO13485 jurisdiction).
You will be responsible for: –
- Interpreting customer requirements and in turn generating technical specifications and associated documents
- Working with R&D to provide expert guidance and Design for Manufacture (DFM) input
- Authoring documentation to permit smooth transfer of manufacture from Research and Development (R&D) to Operations. Documents will include Control Plans, Standard Operating Procedures (SOP’s) and Work Instructions (WI’s)
- Working with validation engineers and equipment engineers to ensure all validation activities are properly planned and executed
- Support manufacturing technicians to investigate, root cause and resolve any nonconformances
- Ensuring that all Critical To Quality (CTQ) elements are established, measured, and achieved
- Becoming expert in all key manufacturing processes
- Ensuring that quality and regulatory procedures are always adhered to
- Identify, propose, and implement process and efficiency improvements
Essential Technical Skills
You will: –
- Be competent in the use of modern manufacturing equipment
- 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
- Be highly competent with MS Office products
Desirable Technical Skills
It would be beneficial if you: –
- Have a working knowledge of biosensor manufacture
- Are experienced in product and process validation
- Have experience in laser processing, screen printing and/or surface modification techniques
- Have experience of executing Gauge Repeatability and Reproducibility (GR&R) protocols
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.