Systems Engineer AU Product Owner
Systems Engineer AU Product Owner
Posted on :
10-04-2025
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1 Vacancy
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Job Description
Why join us
Do work that matters.Were pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day.
Wellfunded and global.Annalise.aiHarrison.ai(raised Australias largest Series B of $129m in 2021.
Work with a bunch of awesome genuine peoplewho are passionate about what they do.
Make an impact. You wont 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.Were big believers in lifelong learning. Youll be given a $1000 personal L&D budget access to LinkedIn Learning plus opportunities for internal mobility and leadership training to fasttrack your career.
Generous parental supportincluding 16 weeks genderneutral paid parental leave and $10000 support for egg or sperm freezing.
About Your Role
As 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 youll do:
- 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 nonfunctional 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 nonconforming products product quality holds and field actions
- Bring the systems thinking to support coordination of software 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 and guidelines including those relating to information security
Your skills and experience:
- 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
Nice to have skills (but not essential):
- 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
$70000 $80000 a year
What were about
Were problem solvers redefining whats possible in medical imaging through AI Technology. Our mission is to raise the standard of healthcare for millions of patients every day.
Yes were a technology company and yes were leveraging the latest AI technologies but people are at the heart of everything we do.
Annalise.aiHarrison.ai. Since then weve scaled rapidly and were focused on creating AI solutions that help radiologists diagnose medical images.
Our first product the worlds most comprehensive AI clinical decisionsupport solution for chest xrays 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 peerreviewed publication Lancet Digital Health journal.
And were just getting started.
Help us shape the future of AI in medical imaging. And most importantly help us make a real difference in peoples lives.
Whats next
If youre inspired by what were up to please apply now and well be in touch soon.
We are proud to be an Equal Opportunity Employer. Diversitys not a buzzword here its in our DNA. Diverse perspectives shape our culture and make our work better. Thats why were 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: We look forward to hearing from you.
Employment Type
Full-Time
Key Skills
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