Systems Engineers

Roles And Responsibilities

Requirements engineering, risk management (per ISO 14971), system and interface design in a Software as a Medical Device (SaMD) context;
Collaborate with Project Management to help plan and manage risk;
Support requirements development, user stories and backlog management in collaboration with Product Management for features, enhancements or fixes, ensuring that UX, Regulatory, Clinical and Marketing needs are met;
Collaborate with QA on developing the procedures and work instructions for our QMS;
Work closely with the development team to evaluate technical design alternatives to achieve desired functionality;
Ensure non-functional requirements including UX, scalability, performance, supportability and reliability are identified and followed;
Develop and maintain a deep understanding of Harrison.AI processes and workflows, as well as an expertise in the functions and data of Harrison.AI systems and applicable regulatory guidance and regulations;
Plan verification and validation testing strategies;
Development and conduct of test protocols; Keep in close step with changes to standards and regulations; and
Comply with all company policies, procedures and guidelines including those relating to information security. This encompasses:
Reading, understanding and complying with the policies and procedures that are relevant to your role within the Information Security Management System;
Report any activity considered likely to compromise an information asset to security team as soon as it becomes known;
You are expected to take responsibility for developing an adequate level of information security awareness, education, and training to ensure the appropriate use of 's information assets; and
You must protect the confidentiality, integrity and availability of information in accordance with the information classification levels outlined in the Information Classification Policy.

Required Skills

Relevant degree in Engineering, Science and/or Information Systems or equivalent;
4+ years’ experience in a professional Engineering role or equivalent; and
Sound understanding of the product development process and life cycle, working within a QMS.

Preferred Qualifications

Relevant experience in with SaMDs, web development & cloud computing (e.g. AWS) platforms;
Knowledge of ISO 13485, 21 CFR Part 820 and QMS implementation;
Experience with scrum agile development methodologies;
Experience with SaMD cyber-security guidance and best practices;
Experience in working on SaMDs submissions for regulatory approvals e.g. FDA, TGA, MDD/MDR; and
Experience in a professional Systems Engineer, Product Owner / Analyst role or equivalent.