Medical Device Developer

3 weeks ago


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

52North - creators of Neutrocheck® is a cutting-edge MedTech company dedicated to revolutionising patient experiences through innovative medical devices. Our mission is to help people live better lives by integrating cutting-edge technology with a human-centred approach.

We are proud to have been crowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards. Our solution, Neutrocheck, is a home-use, low-cost, portable and easy-to-use medical device and app that can identify patients at risk of neutropenic sepsis, a potentially fatal side-effect of chemotherapy treatment.

We are now seeking an experienced Assay Scientist or Biomedical Engineer to join our team and play a key role in the development of our in vitro diagnostic assays. This is an exciting opportunity to contribute to the development of life-changing medical devices and work with a talented team of professionals who share your passion for innovation and excellence.

Job Description:

This role involves developing and optimising in vitro diagnostic assays for use in clinical settings. You will work closely with our Product Development and Clinical Teams as well as our contract research manufacturer to bring innovative medical devices to market. With a strong focus on quality and regulatory compliance, you will ensure that our products meet the highest standards.

Responsibilities:

  • Developing and optimising in vitro diagnostic assays for use in clinical settings.
  • Collaborating with cross-functional teams to design and deliver medical devices that meet customer needs.
  • Ensuring that all products meet quality and regulatory standards.
  • Leading data analysis and interpretation for assay development projects.

Requirements:

  • Assay development and lateral flow biochemistry experience within the in vitro diagnostic space.
  • Understanding of working within and implementing in vitro diagnostic, QMS and regulatory frameworks including training in ISO13485 and ISO9001.
  • Demonstrable experience independently managing multi-stakeholder projects.

We offer a competitive salary of £60,000 - £80,000 per annum, depending on experience, plus a range of benefits including flexible working hours, generous holiday allowance and opportunities for professional development.



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