Design Quality Engineer

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.

Responsibilities

Drive Medical Device Design Control Processes; Lead 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 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

Requirements

Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products; Strong working knowledge of standards such as IEC 62304, ISO 14971, and ISO 27001, and ability to apply these in practical, developer-friendly ways; Solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles; Commitment to quality and ability to drive tasks to completion in a fast-paced, high-growth environment; Excellent communication skills enabling effective work with internal teams (engineers, product) and external partners (auditors, customers)

Nice to have

A Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline; Experience in a start-up or scale-up environment

Benefits

$1,000 annual learning and development budget; $150/month health and wellness allowance; $500 home office budget; 26 weeks paid primary parental leave; 18 weeks paid secondary parental leave; Fertility support up to $10,000; Four weeks of work from anywhere per year; Serious equity