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Heidi Health is seeking a Design Quality & Compliance Engineer to bridge regulatory compliance and agile software development for their AI-powered clinical platform. The company has scaled to support 2.5 million patient sessions weekly across 190+ countries with a freemium medical scribe product that helps clinicians reduce administrative burden.
In this hybrid Sydney-based role reporting to Legal & Regulatory Affairs but embedded within Engineering, you will lead the implementation of medical device design control processes aligned with IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems). Your core responsibilities include:
- Driving design control process implementation and continuous improvement across the software lifecycle
- Partnering with engineers and product managers to ensure requirements, risk controls, verification, and validation are clearly defined, documented, and traceable
- Creating and maintaining technical documentation including requirements specifications, risk management files, verification reports, and change records
- Supporting ISO 13485 and Notified Body audits with focus on design and development aspects
- Translating complex IEC/ISO standards into clear, actionable processes that engineering teams can follow
You should bring prior SaMD (Software as a Medical Device) or regulated healthtech experience, ideally in a startup or scale-up environment. Strong working knowledge of IEC 62304, ISO 14971, and ISO 27001 is essential, along with solid understanding of technical security domains including cloud security, access control, network security, and secure software development lifecycles. A Bachelor's degree in a relevant scientific, engineering, regulatory, legal, or governance discipline is preferred.
Heidi values outcome-driven work, rapid iteration, and building for real-world clinical workflows rather than ideal scenarios. The culture emphasizes sustainable performance, mental health, and trusting individuals to set their own schedules based on outcomes rather than process.
