Active Device Specialist

We pull medical technology from the future to solve human health. Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. ABOUT THIS ROLE: Scarlet’s Devices function is a team of clinicians and software engineers, working together to assess and certify the most innovative and impactful medical device software. We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices. We’ve proved our capabilities with medical device software. It’s now time to expand our remit to cover hardware medical devices. You’ll be our first specialist with deep electrical/active-device expertise, tasked with charting a path towards fast and efficient active device assessments. YOUR RESPONSIBILITIES: - Get authorised to assess the technical documentation of the most innovative active devices in the world - Builds Scarlet’s processes for assessing active medical devices - Become Scarlet’s internal expert in active hardware medical devices, defending our processes to external experts. - Incorporate relevant standards into the assessment process (e.g. the IEC 60601-1 family of standards) - Optimise the assessment of customer data by designing efficient assessment processes KEY SKILLS: - Education - Bachelor’s degree or higher in biomedical engineering, electrical engineering, electrical and mechanical engineering, or similar - Work experience - Minimum of four years of professional experience in the manufacturing, auditing or research of active medical devices - Work experience - Minimum of two years of professional experience in the design, manufacture, testing of active medical devices - Work experience - Knowledge of, and experience implementing, the IEC 60601-1 family of standards (or a relevant subset thereof) DESIRABLE SKILLS: - Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information - Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo - Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks - Excellent communicator - You have exceptional written & verbal communication skills - Hardware expertise - You have knowledge of implantable devices, biocompatibility and sterilisation, including relevant associated standards (e.g. the ISO 10993 series) THE INTERVIEW PROCESS: 1. Intro call with Sandy https://www.linkedin.com/in/wrightsandy/ - 20 mins 2. Interview with Tiri https://www.linkedin.com/in/tirion-h-evans/ and a member of the Devices function - 2 x 30 mins 3. Technical interview with Sandy - 1 hour 4. Culture and values interview with James https://www.linkedin.com/in/james-dewar-78758992/?originalSubdomain=uk and Jamie https://www.linkedin.com/in/jamie-cox-01458b3a/?originalSubdomain=uk - 2 x 30 mins 5. Referencing & offer