Franklin.ai aims to apply the latest methodologies in artificial intelligence (AI) to ultimately put groundbreaking AI tools in the hands of pathologists.

Franklin.ai is a joint venture between global medical diagnostic leader Sonic Healthcare (ASX:SHL) and health technology game-changer Harrison.ai with a mission to raise the standard of healthcare for millions of patients every day.

About your role:

Reporting to our Principal Systems Engineer, you will use your passion for engineering & customer-driven solutions towards the development of break-through medical AI products that positively impact patient lives at scale. You will work alongside product management and provide input to a cross-functional team, including AI engineers, software engineers, RAQA & clinical experts to design and develop a solution in alignment with customer needs.

What you'll be doing:

• Take a lead role in requirements engineering, risk management (per ISO 14971) and system and interface design in a Software as a Medical Device (SaMD) context
• Collaborate with Project Management to help plan and manage risk
• Support requirements development, user stories and backlog management for features, enhancements or fixes
• Collaborate with Product Management ensuring that UX, Regulatory, Clinical and Marketing needs are met
• Work closely with the development team to evaluate technical design alternatives to achieve desired functionality
• Ensure non-functional requirements including UX, scalability, performance, supportability and reliability are identified and followed
• Develop and maintain a deep understanding of Franklin.ai processes and workflows, as well as an expertise in the functions and data of Franklin.ai systems and applicable regulatory guidance and regulations
• Keep in close step with changes to standards and regulations

What we're looking for:

• Experience in a professional Systems Engineer, Product Owner / Analyst role or equivalent
• Sound understanding of the product development process and life cycle, working within a QMS
• Relevant IT degree in Engineering, Science and/or Information Systems or equivalent

Nice to have (but not essential):

• Relevant experience with SaMDs following ISO 62304
• Knowledge of ISO 14971, ISO 13485, 21 CFR Part 820 and QMS implementation
• Experience with SaMD cyber-security guidance and best practices