We're problem solvers, driven by a simple desire to do work that matters. We're constantly evolving ourselves and leveraging the latest AI technologies to create elegant, innovative solutions across medical imaging.
Annalise.ai was formed through a unique partnership between Harrison.ai and Australia's largest medical imaging service provider, I-MED Radiology Network. Leveraging our diverse and extensive medical imaging dataset, Annalise.ai is developing tools to assist Radiologists by seamlessly integrating into their current workflow to provide diagnostic support. Our suite of comprehensive AI-solutions will support radiologists during their end-to-end process of imaging interpretation. And of course, our ultimate goal is to improve patient outcomes for everyone to have a healthy future.
About your role
Reporting to our Lead Systems Engineer, as Senior Systems Engineer you will develop and define software requirements and high-level architecture to deliver a product in accordance with business and quality needs. Your role will see you collaborate with a wide range of stakeholders to deliver quality systems and documentation that meet input requirements. This role will be ideal for a Senior Systems Engineer who is passionate about working on break-through software products that positively impact millions of patient lives at scale. Working closely with our Lead Systems Engineer, you will play a vital role in driving requirements development, risk management and interface architecture design for our AI-enabled radiology product portfolio.
What you'll do:
Requirements engineering, risk management (per ISO 14971), system and interface design in a Software as a Medical Device (SaMD) context;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; andKeep in close step with changes to standards and regulations.
What will help you succeed:
Highly experienced in a professional Systems Engineering role and/or equivalent (e.g. Product Owner/Analyst); Sound understanding of the product development process and life cycle, working within a QMS; andSelf-starter who thrives on working with high levels of ambiguity and has great problem-solving skills.
Nice to have (but not essential):
Relevant experience in with SaMDs, web development & cloud computing (e.g. AWS) platforms;Knowledge of ISO 13485, 21 CFR Part 820 and QMS implementation;Experience in working on SaMDs submissions for regulatory approvals e.g. FDA, TGA, MDD/MDR;Experience with scrum agile development methodologies;Experience with SaMD cyber-security guidance and best practices; Relevant IT degree in Engineering, Science and/or Information Systems or equivalent.
Why you'll enjoy working here:
Do work that matters - we are pioneering innovative and cutting edge AI technologies across the medical imaging sector to help make real, positive impact on patient outcomes around the world.Flexible work - we value life at work and life outside of work. Plenty of flexible work options available with us.Grow your career with us – you'll be given a high degree of autonomy to make your mark in this role. In addition, we are big believers in lifelong learning and will support you to cross-skill in whichever direction you may choose to enhance your career.Competitive remuneration – we know this isn't everything, but it's still an important consideration!We're a start-up with a unique culture - with inclusive social activities, wellbeing initiatives and collaborative team events, we celebrate achievements together and take care of our people.Beautiful office space - located in the heart of Sydney's CBD at Wynyard. Note: our office remains open but we are mostly working remotely and support flexible working.
Thank you for considering this opportunity with us! If this role is of interest to you, please apply now and we'll look forward to reviewing your application shortly.