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 you'll do:

- Conduct requirements management and risk management for [annalise.ai](http://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](http://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 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