Design Quality

Who are Heidi?

Heidi is building an AI Care Partner that supports clinicians every step of the way, from documentation to delivery of care.

We exist to double healthcare's capacity while keeping care deeply human. In 18 months, Heidi has returned more than 18 million hours to clinicians and supported over 73 million patient visits. Today, more than two million patient visits each week are powered by Heidi across 116 countries and over 110 languages.

Founded by clinicians, Heidi brings together clinicians, engineers, designers, scientists, creatives, and mathematicians, working with a shared purpose: to strengthen the human connection at the heart of healthcare.

Backed by nearly $100 million in total funding, Heidi is expanding across the USA, UK, Canada, and Europe, partnering with major health systems including the NHS, Beth Israel Lahey Health, MaineGeneral, and Monash Health, among others.

We move quickly where it matters and stay grounded in what's proven, shaping healthcare's next era. Ready for the challenge?

The Role

As our Design Quality & Compliance Engineer, you'll sit at the heart of Heidi's mission to make world-class care faster and safer through intelligent, compliant technology.

Reporting into the Legal & Regulatory Affairs team, but working day-to-day within Engineering, you'll be the key link ensuring our agile software development practices remain fully aligned with global medical device and information security standards.

Your core mission is to help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of international medical device standards within an agile, iterative environment.

You'll help shape how design inputs, verification, validation, and risk controls are captured, reviewed, and evidenced.

Equally, you'll play a hands-on role in information security and data protection compliance. You'll actively support and participate in external security audits and certifications, to gather evidence, provide technical explanations, and demonstrate that our controls are robust and effective.

This is a hybrid role for someone who can masterfully implement compliance within a modern, agile software culture, enabling engineering teams to build quickly and safely, while ensuring every release stands up to regulatory scrutiny.

What you'll do

• Drive Medical Device Design Control Processes

• Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with international standards.

• Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented, and traceable.

• Support the creation and maintenance of technical documentation, including requirements specifications, risk management files, verification reports, and change records.

• Support external Notified Body audits, with a focus on Design and Development aspects.

• Champion compliance in software development by translating complex and opaque standards into clear, actionable processes that engineering teams can follow.

• Information Security Compliance

• Support and coordinate external security and compliance audits.

• Attend calls and liaise directly with external auditors and stakeholders to ensure a smooth, efficient process and successful completion of all audit activities.

• Take the lead on completing detailed security questionnaires, focusing on all technical aspects of the responses.

• Collaborate across engineering, product, and legal teams to gather required evidence for audits and questionnaires, and participate in calls to provide technical clarifications when needed.

• Aid in the creation and maintenance of technical documentation, policies, and control mappings related to security and compliance.

What we'll look for:

• SaMD Experience: Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment. Standards: Strong working knowledge of standards such as IEC 62304, ISO 13485, ISO 14971, and ISO 27001, and the ability to apply these in practical, developer-friendly ways.

• Technical Skills: A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.

• Proactive & Detail-Oriented: A commitment to quality and the ability to drive tasks to completion in a fast-paced, high-growth environment.

• Collaboration & Communication: Excellent communication skills, enabling you to work effectively with internal teams (engineers, product) and manage external partners (auditors, customers).

• A Bachelor's degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.

What do we believe in?

• We create unconventional solutions to difficult problems and we build them fast. We want you to set impossible goals and make them happen, think landing a rocket but the medical version.

• You'll be surrounded by a world-class team of engineers, medicos and designers to do your best work, inspired by our shared beliefs:

  • We will stop at nothing to improve patient care across the world.

  • We design user experiences for joy and ship them fast.

  • We make decisions in a flat hierarchy that prioritizes the truth over rank.

  • We provide the resources for people to succeed and give them the freedom to do it.

Why you'll flourish working with us ?

• Flexible work with a hybrid environment.

• Additional paid day off for your birthday and wellness days.

• Discounted corporate gym memberships.

• A generous personal development budget of $500 per annum.

• Learn from some of the best engineers and creatives, joining a diverse team.

• Become an owner, with shares (equity) in the company, if Heidi wins, we all win.

• The rare chance to create a global impact as you immerse yourself in one of Australia's leading healthtech startups.

• If you have an impact quickly, the opportunity to fast track your startup career

Help us reimagine primary care and change the face of healthcare around the world.