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- Tasks: Develop tools and processes for quality and regulatory functions in medical device development.
- Company: Flok, a pioneering company in medical device innovation.
- Benefits: Competitive salary, comprehensive medical coverage, equity options, and a vibrant work environment.
- Other info: Enjoy team BBQs, a beautiful workspace, and opportunities for professional growth.
- Why this job: Be the first dedicated QARA Engineer and make a real impact on healthcare technology.
- Qualifications: Exposure to software-as-medical-device development and a passion for learning.
The predicted salary is between 40000 - 50000 £ per year.
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).
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.
What We Offer
- Interesting and challenging work
- In‑person working from a beautiful work space in the Cambridgeshire countryside
- An onsite gym
- A digital health subscription of your choice
- Early stage equity with employee‑friendly terms (via an EMI scheme)
- Comprehensive medical coverage (including dental and optical) and life insurance
- Optional remote working on Wednesdays, with an annual allowance of 10 extra remote days
- Desk setup allowance for your favourite keyboard / mouse / whatever!
- Regular pulse‑checks to help us build a culture we’re proud of
- Monthly team BBQs and desserts on Flok
- A fast paced work environment geared towards excellence and professional growth (with annual training budget)
- Top notch specialty tea and coffee
- A chance to have a big impact in a small early stage team making a difference to the lives of people across the UK
Software Engineer - Internal Regulatory Tooling employer: Flok Health Ltd.
Contact Detail:
Flok Health Ltd. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Software Engineer - Internal Regulatory Tooling
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Flok or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Show off your skills! Create a portfolio or GitHub repository showcasing your projects, especially those related to software-as-medical-device development. This gives us a tangible way to see what you can do.
✨Tip Number 3
Prepare for the interview by understanding ISO standards relevant to the role. Brush up on how they apply to day-to-day activities at Flok. This will show us you're serious about the position and ready to hit the ground running.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows us you’re genuinely interested in being part of our team at Flok.
We think you need these skills to ace Software Engineer - Internal Regulatory Tooling
Some tips for your application 🫡
Show Your Passion for Quality: When writing your application, let us see your enthusiasm for quality and regulatory processes. Share any relevant experiences or projects that highlight your commitment to building high-quality medical devices.
Tailor Your Application: Make sure to customise your application to reflect the specific requirements of the Software Engineer role. Mention your understanding of ISO standards and how they relate to our work at Flok, as this will show you’ve done your homework!
Highlight Collaboration Skills: Since you'll be working closely with various teams, emphasise your ability to collaborate effectively. Share examples of how you've worked with others to streamline processes or solve problems in past roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at Flok Health Ltd.
✨Know Your Standards
Familiarise yourself with the ISO standards mentioned in the job description, especially 13485, 14971, 62304, and 82304. Be prepared to discuss how these standards apply to daily activities and tools at Flok. Showing that you understand these regulations will demonstrate your commitment to quality and regulatory processes.
✨Showcase Your User-Centric Mindset
Since the role requires a keen user-centric mindset, think about examples from your past experiences where you’ve designed or improved processes with the end-user in mind. Be ready to share how you’ve collaborated with different teams to enhance efficiency and reduce friction in workflows.
✨Prepare for Technical Discussions
Brush up on your technical knowledge related to software-as-a-medical-device development. Be ready to discuss how you would approach building internal tools to support product engineers and ensure compliance with documentation requirements. This will show your proactive attitude towards problem-solving.
✨Demonstrate Your Willingness to Learn
Even if you don’t have extensive experience in a similar role, express your eagerness to learn and grow within the position. Share specific areas you’re excited to explore further, such as usability studies or risk management, to highlight your enthusiasm for the role and the company.