Design Quality Engineer

We’re Heidi. We're building the future of healthcare by giving every clinician the earth's finest AI Care Partner. Our platform has absorbed the administrative chaos of 175 million patient visits and supported 67 million clinical hours. Today, we support 2.8 million patient sessions a week across 190+ countries, in 110 languages and over 200 specialties.   Healthcare systems are failing us; clinicians spend more time on documentation than on patients, and the human connection that makes medicine worth practicing is eroding. Our mission is simple: double the world’s capacity for care and strengthen the human connection at its heart.   We found product-market fit with a freemium medical scribe that clinicians love. Now, we're expanding. Every task a clinician hands to Heidi is a patient who feels more attended to, a health system unclogged, and a clinician who gets to be a clinician again. We’ve grown annual recurring revenue from $1 million to $50 million in two years.   To go further, we’ve secured US$340 million: a $100 million Series C led by Blackbird, with Phoenix Court, Point72 Private Investments and Headline, alongside a $240 million growth investment led by General Catalyst’s Customer Value Fund.   If you want to join us in doing work worth shipping, jump in.   The Role   What you’ll do 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 IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape how design inputs, verification, validation, and risk controls are captured, reviewed, and evidenced. 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 IEC 62304, ISO 14971, and ISO 13485. 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 ISO 13485 and Notified Body audits, with a focus on Design and Development aspects. Champion compliance in software development by translating complex and opaque IEC/ISO standards into clear, actionable processes that engineering teams can follow.   What we will 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 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: Excellen