Device Specialist

Другое

• 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: Company’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 Company'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 responsibilitie
• Get authorised to audit management systems and assess the technical documentation of the most innovative devices in the world
• Build and optimise Company’s processes for auditing and assessing management systems and medical devices
• Stay up to date with the latest standards and guidance, and incorporate them into the assessment process
• Help maintain and expand Company’s approvals in various jurisdictions and technologies
• Key skills:
• Education - Bachelor’s degree or higher in engineering, medicine or other relevant science or engineering discipline
• Work experience - Minimum of four years of professional experience in the manufacturing, auditing or research of medical devices
• Work experience - Minimum of two years of professional experience in the design, manufacture, testing of medical devices
• Work experience - Two years of professional experience in the area of quality management.
• 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
• 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