R&D Technical Lead

Are you looking to join an innovative, growing, Scottish SME?

FlexMedical Solutions provide contract design, development and manufacturing services to medical device OEM’s from their site in Livingston.

The business is going through a phase of exciting expansion with numerous new projects launching resulting in new opportunities to join their growing R&D department. We are seeking a senior role in the R+D department to manage complex technical projects. The R&D Technical Lead will report to the CSO and have responsibility for leading customer projects alongside managing a team. Having gained significant experience in the laboratory, you will understand how to develop commercial in-vitro diagnostics and are likely to have some specific experience in electrochemical and other common assay detection methods. With an interest in how products work chemically, fluidically and mechanically it is expected that your work experience goes beyond the lab, and can operate comfortably as both scientist and project manager.

Your time will be spent working on some of our customer specific contracts (developing and manufacturing diagnostic products on their behalf), and also working on internal development programmes.

Due to the size of the business, this is a senior role for an individual who will thrive in a scale-up environment and looking for the opportunity to be a recognised contributor in the growth of the operation.

 

Key Responsibilities

  • Manage a team of scientists to successfully achieve project outcomes efficiently and within timescale.
  • Manage project staff to rapidly identify, root cause and mitigate technical problems in complex

biosensor programme.

  • Design reagents and sensors capable of reliable and safe measurement of analytes.
  • Development of enzymatic, colorimetric, and immune assay formats.
  • Quickly understand client’s biochemical pathways and be able to critique and plan improvement

approach.

  • Collaborate with engineering to ensure electrodes and fluidic cells can deliver sample and reading

output from biochemical assays across a range of detection systems (echem, fluorescence, etc).

  • Demonstrate effective lab craft, operating both in the lab and the office environment.
  • Develop and execute electrochemical methods for external customer requirements, and internal

development programmes.

  • Drive experimental design to make swift robust technical design decisions.
  • Produce all necessary documentation required for product technical files (design history files).
  • Provide impactful and diligent updates for internal and external stakeholders.
  • Work with clients to ensure robust and product focused technical work is scheduled and executed.
  • Author, oversee and execute protocols and reports (R&D, Verification, Validation, SOPs).
  • Develop product and process technical documents to successfully introduce new products and

processes into manufacturing.

  • Communicate effectively with sub-contractors, suppliers, and customers.
  • Provide scientific and project direction to team members, ensuring problems are quickly resolved.
  • Provide scientific input into product and process designs, ensuring optimal performance and client

satisfaction.

  • Produce characterisation reports for customer products and development reports for internal

programmes aligned to the Quality Management System.

  • Drive projects and teams with a daily mindset.

Skills and Experience

  • Qualified to degree level as a minimum in a relevant scientific subject (in lieu of academic qualification, we will consider candidates with significant and demonstrable experience in the IVD industry)
  • Experience of working in a similar role within IVD
  • Experience of managing staff to produce high performing teams, including undertaking recruitment, actively developing team members, conducting appraisals, and managing performance and conduct matters
  • Experienced in designing reagents and formulations from first principles
  • Have experience in electrochemical methods and/or other detection systems in IVD
  • Have experience in IVD product development and validation, and the complete design control life cycle
  • Experience of statistical analysis on data, and presenting high level summaries for communication
  • Understand Good Manufacturing and Good Laboratory Practices (GxP)
  • Experience of working to ISO13485 and 21 CFR Part 820 and familiarity with product and process validation.

We are looking for various levels of opportunity at the moment so feel free to get in touch to discuss what else might be of interest for you!