Systems Engineer | AU (Product Owner)

Why join us?💜 Do work that matters. We’re pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day. 🌏 Well-funded and global. Annalise.ai has a global presence across APAC, EU and US regions. We’re powered by Harrison.ai (raised Australia’s largest Series B of $129m in 2021).🌟 Work with a bunch of awesome, genuine people who are passionate about what they do.💻 Flexible and remote-friendly working.🚀 Make an impact. You won’t be another ‘cog in the wheel’ here. We give full trust and autonomy for you to be heard, to work on big & complex projects – and to make a real difference. 🌱 Grow your career with us. We’re big believers in lifelong learning. You’ll be given a $1000 personal L&D budget, access to LinkedIn Learning, plus opportunities for internal mobility and leadership training to fast-track your career. 🙌 Generous parental support including 16 weeks gender-neutral paid parental leave and $10,000 support for egg or sperm freezing. About Your RoleAs a Systems Engineer at Annalise.ai you will be accountable for delivering high quality AI driven medical device software that positively impacts patient lives at scale. Your role is to provide the systems thinking, systems design, and support to product quality throughout the product lifecycle and ensuring the products meet relevant standards and regulatory requirements. You will also be working with a multidisciplinary team that consists of domain experts in Machine learning/Artificial Intelligence, Clinical Research, Quality Assurance, Software Engineering, DevOps, and Product as part of software releases. What you'll do:Conduct requirements management and risk management for annalise.ai software medical device productsEnsure product development and release process meets applicable standards and regulations by applying knowledge of ISO 13485 Quality Management System, ISO 14791 Risk Management, IEC 62304 Software Lifecycle and other applicable standardsProvide input on medical device development, systems thinking and product quality processes – leading annalise.ai to be more efficient and effective at scaled developmentCollaborate with Project Management to help plan and manage riskUnderstand the business needs, customer needs, mandatory requirements from applicable standards and regulatory requirements to derive the system and design requirementsEnsure non-functional requirements such as scalability, performance, supportability and reliability are identified and followedContribute to the investigation of product quality issues, including but not limited product complaints, product related NCRs and CAPAs, non-conforming products, product quality holds and field actionsBring the systems thinking to support coordination of software releases, ensuring functionality developed by multiple software teams are appropriate for the releaseSupport in the development and implementation of quality related policies and procedure to ensure compliance with applicable standards and regulations; and Comply with all company policies, procedures and guidelines including those relating to information security Your skills and experience:Relevant IT degree in Engineering, Science and/or Information Systems or equivalentExperience in engineering products in a regulated environment (for example in healthcare, avionics, naval, automobiles), preferably Healthcare3 years’ experience in a professional Engineering role or equivalent; and Sound understanding of the product development process and life cycle, working within a regulated environment Nice to have skills (but not essential):Relevant experience with AI based solutionsRelevant experience in with SaMDs, web development & cloud computing (e.g. AWS)platforms; and Experience in working on SaMDs submissions for regulatory approvals e.g. FDA, PMDA Japan, TGA, MDD/MDR What we’re about We're problem solvers, redefining what’s possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day.Yes, we’re a technology company and yes, we’re leveraging the latest AI technologies, but people are at the heart of everything we do. Annalise.ai was formed in early 2019, powered by Harrison.ai. Since then, we’ve scaled rapidly and we’re focused on creating AI solutions that help radiologists diagnose medical images.Our first product, the world's most comprehensive AI clinical decision-support solution for chest x-rays, is already in made available to 1 in 2 radiologists in Australia and rolling out to hundreds more, globally. This solution is capable of detecting 124 findings and was recently featured in a peer-reviewed publication, Lancet Digital Health journal. And we’re just getting started. Help us shape the future of AI in medical imaging. And most importantly, help us make a real difference in people’s lives. What’s next?If you’re inspired by what we're up to, please apply now and we'll be in touch soon.We are proud to be an Equal Opportunity Employer. Diversity’s not a buzzword here, it’s in our DNA. Diverse perspectives shape our culture and make our work better. That’s why we’re committed to building inclusive teams that represent a variety of backgrounds and skills. If you need any reasonable adjustments, accessibility assistance or would like to note which pronouns you use at any stage of our hiring process, just contact us at accommodations: people@annalise.ai. We look forward to hearing from you.