MedTech Product Development Specialist

1 day ago


Cambridge, Cambridgeshire, United Kingdom 52North - creators of Neutrocheck® Full time
About 52North Health

We are a pioneering medtech company developing cutting-edge technologies to revolutionise patient experiences and set new industry standards. Our innovative approach focuses on integrating technology with a human-centred approach, ensuring our products meet the needs of healthcare professionals and patients alike.

As a leading developer of in vitro diagnostic assays, we are seeking an experienced Senior Scientist to join our team. This is a unique opportunity to take the lead on the development, optimisation, validation, and verification of lateral flow assays. You will collaborate closely with our Product Development and Clinical Teams, as well as our contract research manufacturer, to bring cutting-edge solutions to market.

The successful candidate will have a strong background in assay development and lateral flow biochemistry within the in vitro diagnostic space. They will be responsible for day-to-day lateral flow assay development, including supporting scale-up, quality processes, and verification/validation of current assays. Additionally, they will lay the groundwork for future pipeline products and work within relevant ISO standards and in vitro diagnostic regulatory frameworks.

This is an exciting opportunity for an organised and flexible individual who is confident and comfortable leading their own project, using initiative and developing product and business plans. You will have support from our team, partners, and network throughout. The position involves collaborative work between the state-of-the-art Cancer Research UK Cambridge Campus and our main office space in West Cambridge.

Key Responsibilities:

  • Developing, optimising, validating, and verifying lateral flow assays for in vitro diagnostics
  • Managing lab space and documentation within our ISO 13485 quality management system
  • Collaborating with clinicians, patients, and engineering partners to design and deliver products while evaluating and managing risks related to the product
  • Contributing to project management related to assay development, including working closely with our CROs and acting as the first port of call for technical problem-solving
  • Communicating with and contributing to reporting for team members, funders, investors, and collaborators on progress of product development
  • Lead data analysis and interpretation for assay development projects, using statistical methods and bioinformatics tools to ensure accurate and reliable results, and provide actionable insights for product optimisation

Salary Range: £60,000 - £80,000 per annum, depending on experience

Benefits: A comprehensive benefits package, including hybrid working, flexible schedule, generous holiday allowance, maternity, paternity, and adoption policies, EMI share option scheme, pension scheme, health insurance, dental and optical coverage, wellbeing engagement programme, and social activities.



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