Design Quality Engineer

About the role

You will own the end-to-end implementation of medical device compliance processes within our agile software delivery pipeline. This role requires you to act as the primary guardian of design control, ensuring that every feature released meets the highest standards of safety and regulatory rigor. You will be responsible for embedding IEC 62304 and ISO 14971 directly into the daily work of engineers, making compliance a practical enabler rather than a bureaucratic hurdle. You will collaborate closely with clinical advisors to translate real-world clinical risks into technical requirements and verification strategies. This position gives you direct ownership of the frameworks that protect both patient safety and the company's regulatory standing. You will be the trusted advisor who helps engineering teams navigate the complex landscape of global health regulations. Ultimately, you will ensure that Heidi's technology is not only effective and intelligent but also built to the most stringent quality and safety standards in the world.

Key facts

What you'll do

Lead the practical implementation of IEC 62304 software lifecycle processes within an agile development environment.

Partner with product managers and engineering leads to define and document design inputs that translate clinical needs into traceable technical requirements.

Develop and maintain comprehensive risk management files in alignment with ISO 14971, identifying and mitigating potential hazards proactively.

Create and manage verification and validation strategies, ensuring all testing activities are planned, executed, and evidenced to meet regulatory standards.

Own the creation and upkeep of technical documentation, including software specifications, traceability matrices, and user needs documentation.

Support the preparation for and successful passage of external audits, including ISO 13485 quality management system assessments and Notified Body inspections.

Champion the translation of complex regulatory standards into clear, actionable procedures that software developers can easily understand and follow.

Establish and maintain robust change control processes, ensuring all modifications are documented, assessed for risk, and validated appropriately.

Collaborate with security engineers to ensure technical security controls related to access management and data protection are integrated into the design and compliance strategy.

Act as the central compliance authority for design and development activities, providing guidance and oversight to ensure consistent adherence across all engineering teams.

Requirements

You must possess a Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline.

You must have prior professional experience working on Software as a Medical Device (SaMD) or other regulated health technology products.

You must have strong working knowledge of medical device and software standards, including IEC 62304, ISO 14971, and ISO 13485.

You must demonstrate a solid understanding of technical security domains such as cloud security, access control, network security, and secure software development practices.

You must be highly detail-oriented and capable of driving complex compliance tasks to completion in a fast-paced, high-growth environment.

You must possess excellent communication and interpersonal skills to effectively collaborate with internal engineering and product teams.

You must be able to work effectively with external partners, including auditors, regulatory consultants, and notified bodies.

You must be committed to a proactive and quality-first mindset, ensuring that safety and regulatory considerations are embedded in every design decision.

Nice to have

There are no preferred items listed in the source material for this role beyond the core requirements.

Practical notes

This is a hybrid role based in Sydney. The specific number of required office days is not detailed in the source material. Travel requirements are not specified. There are no visa sponsorship details provided for this position. The job listing contains no explicit deadline for applications. You are expected to work within the standard full-time schedule as defined by company policy.