Remote Systems Engineer

Summary

Join a global company pioneering AI software to diagnose medical images and improve healthcare standards. As a Systems Engineer, you'll deliver high-quality AI-driven medical device software that positively impacts patient lives at scale.

Requirements

• 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
• 5 - 8 years’ experience in a professional Engineering role or equivalent
• Sound understanding of the product development process and life cycle, working within a regulated environment

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 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
• Comply with all company policies, procedures and guidelines including those relating to information security

Preferred Qualifications

• Relevant experience with AI based solutions
• Relevant experience in with SaMDs, web development & cloud computing (e.g. AWS) platforms
• Experience in working on SaMDs submissions for regulatory approvals e.g. FDA, PMDA Japan, TGA, MDD/MDR