We are seeking a passionate Project Engineer to work with us to design and develop medical devices and associated processes, with a focus on quality management.
Reporting to the QARA Manager, you will also work closely alongside other members of the team as well as external clinical and academic collaborators.
Candidates should have an interest in start-ups and emerging technologies, with ambitions to grow with the company as it moves towards the clinic. As a member of our team, you will be responsible for making decisions that have an enormous impact on the future of our business from day one and be expected to work with significant autonomy.
· Device development – engaging with clinical users to design surgical instruments, software tools and other devices.
· Device verification and validation.
· Help to develop surgical processes and design/deliver associated training to surgeons.
· Process development and establishing subcontract manufacturing, validation and processes.
· Apply quality management system (ISO 13485) and audit activities internally and externally.
· Engage with Competent Authorities through pre-submission processes to guide ongoing development
· Participating in and compiling risk management (ISO 14971), medical device technical documentation and post market surveillance.
· Support other members of the team in managing research projects, writing grant applications, patents, and scientific publications.
· Representing the company at meetings with clinicians, healthcare regulators and contractors.
· Masters (MEng/MSc) in Mechanical or Biomedical Engineering or other relevant discipline.
· Technical knowledge of mechanical product (preferably medical device) design, testing and manufacturing.
· A team player with a ‘can-do’ problem-solving mindset & dedicated work ethic.
· Attention to detail and a disciplined approach to their work.
· Excellent communicator in both oral and written format.
· Fast learner, who can hit the ground running.
· Experience of SolidWorks or similar CAD package.
· Experience of Medical device development & associated technical documentation.
· Experience of quality management systems, particularly ISO13485 & 14971.
· Experience of inter-disciplinary research.
· Experience of Manufacturing process validation.
· Competent with MATLAB or other programming language.
· Competitive compensation & share options in a rapidly growing start-up.
· Autonomous work environment.
· Opportunities for career growth and personal development.
· Working alongside a small, passionate, and friendly team.
Work will primarily be based at Alderley Park, the UK’s leading life science campus. This vibrant community includes world-class laboratory facilities, modern office facilities and diverse food and drink offerings. Based in the Cheshire countryside, Alderley Park also has excellent amenities including:
· Onsite Gym, Health, and fitness studio.
· Onsite restaurant, cafes, and pub.
· Walking, running, and cycling routes set within 400 acres of idyllic parkland.
Alderley Park has excellent transport links to Manchester, ranked the best UK city outside of London for the availability of retail and leisure, with four national parks within an hour’s drive.
This role would be full-time. The position is not eligible for remote work. If you are not based within a commutable distance, you will be expected to relocate.
How to Apply:
Apply with your CV & cover letter to [email protected]
For more information about who we are, visit our website at www.qvbio.co.uk and if you have any additional queries please contact us at [email protected].
What happens next:
If successful in the first stage, you will be invited for an initial remote interview. We endeavour to inform all applicants of the status of their applications throughout the process.
Alderley Park, Cheshire