Design Quality Engineer

About the role

The Design Quality & Compliance Engineer will sit at the heart of Heidi's mission to make world-class care faster and safer through intelligent, compliant technology. Reporting to the Legal & Regulatory Affairs team while working within Engineering, this role ensures software development practices remain aligned with global medical device and information security standards. The successful candidate will lead the implementation of IEC 62304, ISO 14971, and ISO 13485 within an agile environment.

Responsibilities

• Drive Medical Device Design Control Processes by leading the implementation and continuous improvement of processes across the software lifecycle.
• 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 IEC/ISO standards into clear, actionable processes for engineering teams.

Required skills

• SaMD
• IEC 62304
• ISO 14971
• ISO 27001
• Cloud security
• Access control
• Network security
• Secure software development

Nice to have

• ISO 13485

Qualifications

• Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline

Benefits

• Private medical and dental cover
• Mental health and coaching support
• Wellness stipend
• Home office budget
• Learning and development budget
• Paid parental leave
• Fertility support
• Work from anywhere allowance
• Recharge days

About the Company

Heidi is building an AI Care Partner to double the world’s capacity for care and strengthen the human connection in medicine. The company has supported millions of patient sessions globally and is backed by major investors including General Catalyst and Blackbird.