R&D Scientist II

Jul 25, 2022 | RECRUITMENT, SCIENCE

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 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.

 

Role Description 

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 electrochemical and other common assay detection methods. With an interest in how products work chemically, mechanically, and electrically it is probable that your work experience goes beyond the lab.

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 scale-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.

 

Key Responsibilities

Reporting to the Technical Lead, you will: –

  • Design and 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.
  • Work with clients to devise and execute experimental designs (DoE’s) and create summary reports for discussion.
  • Author, oversee and execute protocols and write reports.
  • Develop product and process technical documents to successfully introduce new products and processes into manufacturing.
  • Communicate effectively with sub-contractors, suppliers, and clients.
  • Provide scientific input into product and process designs ensuring optimal performance and client satisfaction.
  • Produce characterisation reports for customer products and development reports for projects, aligned with 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

Essential  

  • As a minimum, you will hold a degree level qualification in a relevant scientific subject.
  • You will have demonstrable, 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 and complex laboratory equipment.
  • Experienced in designing and building reagents and formulations from first principles.
  • Significant experience in electrochemical methods or other test measurement systems.
  • Experience of designing experimentation to resolve technical uncertainty through scientific rigor and root cause analysis.
  • Experience in IVD product development and familiar with Design Control concept.
  • Able to perform statistical analysis on data to drive decision making.
  • Understand Good Manufacturing and Good Laboratory Practices (GxP).
  • Experience of working to ISO13485 and / or 21 CFR Part 820, and familiar with product and process validation.

Desirable

  • A Green/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).
  • Understand Design for Manufacture (DFM) methodology.
  • Experienced using statistical tools such as Minitab and understand Design of Experiments methodology.
  • Experienced in reagent chemistry as applied in IVD products.
  • Experienced in surface chemistry: modification and analysis.
  • Experience in microfluidic devices.
  • People management experience would be advantageous.

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 lot of variety and excitement; initiative will be rewarded, and personal development is a given.

Apply Now

Please send your CV and a covering letter, outlining your suitability for the post:

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