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. As a Systems Engineeryou 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 willalso be working with a multidisciplinaryteam that consists ofdomain experts in Machine learning/Artificial Intelligence, Clinical Research, Quality Assurance, Software Engineering, DevOps, and Productas part of software releases.
Key responsibilities
Conduct requirements management and risk management for annalise.ai software medical device products
Ensure 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 standards
Provide input on medical device development, systems thinking and product quality processes – leading annalise.ai to be more efficient and effective at scaled development
Collaborate with Project Management to help plan and manage risk
Understand the business needs, customer needs, mandatory requirements from applicable standards and regulatory requirements to derive the system and design requirements
Ensure non-functional requirements such as scalability, performance, supportability and reliability are identified and followed
Contribute 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 actions
Bring the systems thinking to support coordination ofsoftware releases, ensuring functionality developed by multiple software teams are appropriate for the release
Support 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 andguidelines including those relating to information security
Minimum Qualifications
Relevant IT degree in Engineering, Science and/or Information Systems or equivalent
Experience in engineering products in a regulated environment (for example in healthcare, avionics, naval, automobiles), preferably Healthcare
3 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
Preferred Qualifications
Relevant experience with AI based solutions
Relevant 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 4 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.
