Software Engineer, Foundation Partners
Internal Regulatory Tooling
+ Early stage equity
4 days a week in office (Comberton, Cambridgeshire )
People strategy & operations consulting
Open for applications
People strategy & operations consulting
1-20 employees
Open for applications
+ Early stage equity
4 days a week in office (Comberton, Cambridgeshire )
1-20 employees
Company mission
To align clients' people strategy with their business strategy to help them achieve their mission.
Role
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)
Our take
Foundation Partners offers consulting to help businesses build strong people, culture and HR operations. It offers three service packages ranging from advice and guidance to the embedding of a fractional people team.
With a view that thriving people build thriving businesses, Foundation Partners provides companies with the experience and support to empower their people towards creating business success. It does so both on a strategic level as well as the day-to-day, making sure that companies can build for the future while ensuring their teams have what they need today.
With a wealth of experience within the company, Foundation Partners is a stand-out potential partner for any business that wants to build a better people function. Some of the clients the company has worked with include Vinted, Monzo, JustGiving, Accenture and Checkout.com.
Steph
Company Specialist at Welcome to the Jungle
Company
Company benefits
- 25 day's holiday
Company HQ
Fitzrovia, London, UK
Leadership
Anouk Agussol
(Managing Partner)Director at the Amplified People Group and JBM, as well as Founder / CEO at Unleashed.Company. They are also a Fellow at Foundervine and have extensive experience in People Strategy and Culture.
Andy Meikle
(Managing Partner)Director at the Amplified People Group, JBM and Unleashed. Is an Investor / Advisor for The Octopus Club and has extensive experience in People and Operations.
Andrew Richardson
(Managing Partner)Director at the Amplified People Group, JBM and Unleashed. Is an Advisor at Abingdon Software Group and Antler and has extensive experience in People and Operations.
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