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 rapid-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

📌 Software Engineer (Cambridge)
🏢 Foundation Partners
📍 Cambridge