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. 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.

Responsibilities

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

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 the ability to apply these in practical, developer-friendly ways; A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles; A commitment to quality and the ability to drive tasks to completion in a fast-paced, high-growth environment; Excellent communication skills, enabling you to work effectively with internal teams (engineers, product) and manage external partners (auditors, customers)

Nice to have

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

Benefits

Comprehensive private medical and dental cover through Bupa; 24/7 mental health, coaching and wellbeing support through Sonder; £100/month Healthy Heidi's wellness stipend; £500 home office budget; £700 annual learning and development budget; 26 weeks paid primary parental leave and 18 weeks paid secondary parental leave; Fertility support up to £7,000; Up to four weeks of work from anywhere per year; Recharge Days after major milestones and busy periods; 10 days per year of clinical leave for eligible clinical roles; Hybrid working environment with 3 days in the office