Project Manager (Medical Devices, IVD, Assay Development)


Owlstone Medical has developed a breathalyzer for disease for the early detection of cancer, inflammatory and infectious disease. Our mission is to save 100,000 lives and $1.5B in healthcare costs. We need  to add outstanding Project Managers with experience in Medical Devices, IVDs or Assay development to help us achieve it.

About the Job:

Your objective would be to work with our multi-disciplinary development teams and lead the delivery of complex projects that could include the development of medical devices, In Vitro Diagnostics test systems or Assay developments, depending on your background and expertise. This is a key position of responsibility and your success in this role will be central to the success of the company.

Your principal activities will include:

  • Management of highly regulated projects from requirements definitions and systems requirement specifications through to delivery.
  • Managing timelines, resource, budgets and risks and reporting on project progress to senior management and other internal stakeholders.
  • Run the projects complying with relevant quality standards and regulations (e.g.EU and FDA)
  • Working with the project engineering team to solve challenging science, electronics, software, and systems engineering problems through a hands-on approach.
  • Guiding and contributing to systems engineering activities including requirements analysis, risk management, system architecture, usability and integration/verification/validation activities
  • Supporting business development activities within the medical sector including formulation of technical bids and proposals.

The role is based in our Cambridge UK office.

About You:

We need an innovative, experienced and delivery focused individual with the drive and enthusiasm to push forward relentlessly in a fast paced and challenging environment. You will therefore need to have:

  • B.A./B.Sc. preferably in Science or, Engineering.
  • Proven track record of project management of Assay development, In Vitro Diagnostics or other Medical Devices.
  • Team oriented attitude with the ability to manage conflicting priorities.
  • A good working knowledge of medical device development practices, standards and regulations (e.g ISO 13485)
  • Ability to communicate ideas and work flexibly within a dynamic, multidisciplinary team.

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com. Every time you breathe out there are hundreds of chemicals on your breath – some are telltale markers of disease, which our microchip chemical sensor technology is able to detect. They key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage it drops to about 5% – unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on patients’ lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone is the place for you.

To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to Reveal email address.