Company Overview
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.
Role Description
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 adept at successfully managing several client projects at the same time.
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
- A degree in a technical / engineering subject. Consideration may be given where significant industry experience can be demonstrated in lieu of academic qualification
- Demonstrate considerable proven experience in a similar role
- Be fully versed and competent in the use of modern manufacturing equipment (e.g. lasers, robotics, liquid dispensing) and metrology equipment (e.g. CMM, contact angle)
- Understand and practice 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
- Confidently perform statistical analysis on data using tools such as Minitab
- Understand current manufacturing methods including rapid prototyping
- Experience of working to ISO13485 and 21 CFR Part 820
- People management experience
Desirable
- Working knowledge of biosensor design and development
- Experienced in product and process validation
- Experience in laser processing, screen printing or surface modification techniques
- A Green or Black Belt qualification in six sigma / process excellence
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 great deal of variety and excitement to your working day. Initiative will be rewarded and personal development is guaranteed.