Software Safety Engineer

Requirements

• Education – A degree in computer science or related discipline
• Work experience – Minimum of four years experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research
• Work experience – Minimum of two years in the design, development or testing of medical device software (or other critical software)
• Work experience – Practical experience in conducting performance, verification and validation testing and/ or assessing performance, verification and validation test protocols, data and results for medical device software
• Work experience – Practical experience in programming, demonstrating knowledge of one or more programming languages, software testing and debugging techniques
• Work experience – Knowledge of the fundamental principles of programming, software development life-cycle processes, software verification and validation testing, software configuration management and problem resolution techniques along with medical device cybersecurity, interaction between medical software and its environment and data protection
• (Desirable) Ferociously curious – You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
• (Desirable) Excellent communicator – You have exceptional written & verbal communication skills
• (Desirable) Highly adaptable – You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks
• (Desirable) Guidance knowledge – You have knowledge or training in the relevant standards and guidance relevant for medical device software (e.g. IEC 62304, IEC 81001-5-1)
• (Desirable) AI fluent – You have strong technical knowledge of modern generative AI (e.g., LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring) and have a rich understanding of how these systems work – and where they fail

What the job involves

• Scarlet’s Devices function is a team of clinicians, AI experts, 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
• As we continue to scale our activities and certify more and more medical devices, we need software expertise to provide support across all stages of the customer journey
• You’ll join a team of software experts, conducting swift and accurate device assessments, whilst providing knowledge and expertise to internal functions and external stakeholders
• Get authorised to assess the software lifecycle processes of the most innovative medical devices in the world
• Collaborate with a multidisciplinary team on technical documentation assessments
• Create content to help explain complex regulatory topics to customers and prospects
• Screen and action regulatory insights from the latest research, standards and guidance
• Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers
• Work with our Product, Engineering, Design and Applied ML functions to build and improve our systems
• Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies

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