Software Engineer

Who you are

• You don't need to have many years of experience in a role just like this, but we are looking for exposure to software-as-medical-device development and a desire to learn more
• ‍If you like:
• Solving hard problems at the intersection of technology and healthcare
• The pursuit of excellence—helping each other to do the best work of our careers
• Working in an in-person collaborative environment
• Taking ownership to have significant impact in a fast-growing mission-driven company with big ambitions
• Then you'll fit right in!

What the job involves

• We're looking for someone with a software engineering background to take significant responsibility in developing tools and processes for our quality and regulatory function, helping us to build high quality medical devices
• You’d be the first dedicated QARA Engineer at Flok, and as such would have influence and ownership in the role
• We think of the role as an application of an engineering approach to the optimisation of our processes, specifically to meet the requirements of medical device development standards
• You'd be building tools and processes to support our product engineers so the role requires a keen user-centric mindset and ability to work with people across the business
• You’d be responsible for:
• Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools
• Helping us design, implement and improve processes for meeting the requirements
• Working closely with the teams involved in each process (particularly clinical, product and engineering) to make the processes more efficient and easier to run: spotting opportunities to eliminate friction, bottlenecks, and unnecessary overhead or work
• Building internal tools where possible to improve processes
• Helping the engineering team to ensure our device(s) technical file documentation is complete, particularly around the change process, risk management, requirements capture and V&V
• And potentially other activities related to QARA, including designing and running usability studies for our device(s)

Benefits

• 25 day's holiday