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 our site in Livingston.
We are going through a phase of exciting expansion and are seeking a NPI Scientist to join our tight-knit team and play an active role in the company's expansion. This role is looking for a qualified scientist to bring hands-on, technical expertise to the business and having gained experience in the laboratory, you may have an understanding of in-vitro diagnostics and may have some specific experience in reagent development and common assay detection methods.
As a contract business, we work on multiple projects simultaneously, and it will be a requirement for this role to operate across multiple short-term projects with the role developing new products and processes in unison with our design control process. Working for a start-up organisation will provide you with a fantastic opportunity to make your mark and implement your ideas.
Key Responsibilities
Reporting to the CSO, you will: -
Develop reagent formulations necessary to investigate proposed sensor technologies.
Develop and execute reagent experiments for external customer requirements, and internal development programs
Develop reagent deposition methods, and sensor build processes to ensure rapid, consistent, and precise sensor production for development programs.
Author, oversee and execute R&D protocols and reports, ensuring compliance with the
requirements within the GLP environment.
Develop product and process technical documents to successfully introduce new products and processes into manufacturing.
Design, execute and report lab experiments in support of external client projects and internal development programmes.
Communicate effectively with sub-contractors, suppliers and customers
Essential Technical Skills
You will: -
Be competent using routine laboratory equipment.
Experienced in building reagents and formulations from first principles
Have experience in IVD product development.
Be competent using complex test apparatus such as viscometers and contact angle equipment
Understand Good Manufacturing and Good Laboratory Practices requirements (GxP)
Have worked to ISO13485 and 21 CFR Part 820 and will be familiar with design control, & process validation.