Medical Device Specialist

We pull medical technology from the future to solve human health. Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar. Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale. About this role:Scarlet’s Devices function is a team of clinicians, software engineers and device specialists, working together to audit, assess and certify the most innovative and impactful medical devices.We pride ourselves on delivering efficient audits and fast technical assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices.We are both the designers and operators of our auditing and assessment processes, working with Scarlet's internal team of software developers, product designers, and ML engineers, to develop world-class tooling to support conformity assessment.We’ve proven our capabilities with medical device software and are actively expanding our scope to include hardware medical devices.Your responsibilities: Get authorised to audit management systems and assess the technical documentation of the most innovative devices in the world. Collaborate with product, engineering, and ML to optimise our processes and continue to scale them. Collaborate with teammates in the operations function to expand the scope of Scarlet’s approvals to enable our customers to reach more people. Key skills: You've got a bachelor’s degree or higher in engineering, medicine or other relevant science or engineering discipline You've worked for 4+ years designing, building and/or researching medical devices You've got 2+ years of experience with quality management systems You have experience in software design, verification and validation You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information You like going down rabbit holes, understanding deeply how things work, and challenging the status quo You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks You have exceptional written & verbal communication skills The interview process: Intro call with Sandy - 30 mins Team interviews - 2 x 30 mins Technical interview - 1 hour Culture and values interview with James and Jamie - 2 x 30 mins Referencing & offer