Lead Systems Engineer

Lead Systems Engineer - Medical Device Development

At Entia we are transform the experience of living with life-changing health conditions. At Entia we are building products that help give people with cancer more time, whether that’s more days to spend with family and friends in the last months of life or helping people to beat cancer through more personalised treatment.

To help us achieve this, we are challenging how medical devices and development processes are developed and used so that our innovations reach the market quicker and ultimately help more people. We are continually improving how we work as a company and how quality and regulatory compliance can be seamlessly integrated into everyday activities. We believe our industry can do better and we want to show how to deliver products quickly, safely and effectively.

We are looking for a leader who can help develop our approach to delivering medical devices and associated processes in a way that helps us better realise our mission. We need someone who is excited to poke holes in the status quo and establish what the real problems to be solved are across the business. Someone who sees the regulatory and quality landscape as a world of opportunities rather than constraints. We need an individual capable of realising these opportunities in a way that aligns with how we develop products and helps nurture a systems engineering culture across all our activities.

You will be defining the way we work and selecting the best tools to use. You will be highly aware of the challenges coming up over the next 6-9 months and will be providing input into the strategic plan to ensure we remain competitive over this time horizon and beyond.

Our fundamental driving belief is that time is precious. Spend it doing something that matters.

To deliver our mission, we believe we need people who:

• Share our values and believe in our mission wholeheartedly
• Are curious about the world around them, not just their area of expertise. People who can’t help but ask “Why?”
• Like working with a diverse range of people who offer a lot of different skills
• Are great at building relationships and understanding how to identify problems and opportunities
• Willing to learn by trying new things
• Can adapt, respond and pivot to push the boundaries of innovation; to define the fastest route that brings the most value to Entia
• Believe that we succeed as leaders by developing and enabling others over ourselves
• Are excited by the unknown and challenging the way things are “usually done”
• Would like to mentor and coach others in the organisation

For this role we would like you to have:

• Experience empowering teams to develop, design and test complex systems within a regulatory framework and providing/obtaining guidance and vision of the regulatory approach
• Delivered hardware and software products in a regulated industry sector
• Ability to integrate effectively as part of a collaborative and multidisciplinary team
• A love of working with Product Managers to develop the scope of the product and to embrace change
• A passion for, and an emerging track record of, making changes to the way a company operates to help it deliver things that matter

If you enjoy working in a highly rigid, structured environment with requirements signed off before development work starts, and are uncomfortable with uncertainty, swipe left!

And you may even have:

• Working knowledge of or experience working with IVDR, MDR, IVDD, ISO 13485 ISO 14971, ISO 27001
• Worked in a startup environment or in an organisation that works differently
• Helped develop IVD products
• Mapped out the FDA’s inner workings and read some of CFR 820
• Exposure to the many other standards in the medical space (ISO 62366, ISO 60601, ISO 61010)
• Worked out what on earth is happening with Software as a medical device (SaMDs) in Europe
• Experience as a line manager for small teams

Why is Entia fantastic:

• The chance to make a major impact on the people you work with and for millions of people living with cancer
• A flexible and fun work environment filled with a very diverse group of passionate and incredibly capable people, where we expect you to challenge the status quo and make real impact
• Market leading benefits designed to give us more quality time outside of work; including a generous 43 days off each year (30 days flexible leave, 8 bank holidays taken whenever you like and 5 days of company shutdown at the end of each year), volunteering days, sabbatical opportunities and a generous (and equal) Maternity, Paternity and Adoption policy that starts to accrue as soon as your probation finishes
• Opportunities to learn and grow with a dedicated training budget to spend on whatever you like
• Hybrid and flexible working with a lively and collaborative office space in Central London
• Regular team-building company events including away days, lunches, an annual team trip and more

You will:

• Build a culture of systems engineering in every member of the Entia team
• Be proactive in identifying regulatory compliance issues in any Entia function
• Be, or find, the expert to solve regulatory technical queries
• Oversee our information management systems
• Line manage quality and systems engineers as well as others who feel they may benefit from your guidance