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Heidi Health is seeking a Design Quality & Compliance Engineer to bridge regulatory excellence and agile software development in healthcare AI. Reporting to Legal & Regulatory Affairs but embedded within Engineering, you'll 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 processes across the software lifecycle, partnering with engineers and product managers to ensure requirements, risk controls, verification, and validation are clearly defined and traceable. You'll support creation and maintenance of technical documentation including requirements specifications, risk management files, verification reports, and change records. You'll champion compliance by translating complex IEC/ISO standards into actionable processes that engineering teams can follow, and support external ISO 13485 and Notified Body audits with focus on design and development aspects.
The ideal candidate brings prior SaMD (Software as a Medical Device) or regulated healthtech experience, ideally in a startup or scale-up environment. You'll have strong working knowledge of IEC 62304, ISO 14971, and ISO 27001, with the ability to apply these standards in practical, developer-friendly ways. Technical skills in cloud security, access control, network security, and secure software development lifecycles are essential. You're proactive, detail-oriented, and excel at collaboration—able to work effectively with internal teams and manage external partners like auditors and customers. A Bachelor's degree in a relevant scientific, engineering, regulatory, legal, or governance discipline is preferred.
Heidi Health has achieved product-market fit with a freemium medical scribe used by clinicians across 190+ countries, processing over 2.5 million patient sessions weekly. The company's mission is to double global healthcare capacity and strengthen the human connection at medicine's heart by eliminating administrative chaos that consumes clinician time.
