SaMD Design Quality & Compliance Engineer

heidihealth.com.au; Greater London; Hybrid; GBP 90,000 - 120,000; Full time

Benefits offered by this job

Private medical cover

Dental cover

Mental health support

Wellbeing stipend £100/month

Home office budget £500

Learning & development budget £700

Parental leave

Hybrid work

Job summary

Heidi is hiring a Design Quality & Compliance Engineer to ensure software design and development meet global medical device requirements. You will align agile practices with IEC 62304, ISO 14971 and ISO 13485, shaping design inputs, verification, validation and risk controls.

You’ll work within Engineering and report to Legal & Regulatory Affairs, collaborating with auditors and product teams to maintain compliant software releases and robust documentation.

Qualifications

• SaMD experience in regulated healthtech startups.
• Knowledge of IEC 62304, ISO 14971, ISO 27001 with practical application.
• Strong security domain knowledge: cloud, access control, network security, secure SDLC.
• Proactive, detail-oriented with ability to drive tasks to completion.
• Excellent collaboration and communication with engineers, product, and auditors.
• Bachelor’s degree or higher in a relevant field is a plus.

Responsibilities

• 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 IEC/ISO standards into clear, actionable processes.

Skills

SaMD Experience

IEC 62304

ISO 14971

ISO 27001

Cloud security

Access control

Network security

Secure SDLC

Attention to detail

Proactive mindset

Team collaboration

Communication

Education

Bachelor’s degree or higher (relevant field)

Job description

Heidi is hiring a Design Quality & Compliance Engineer to ensure software design and development meet global medical device requirements. You will align agile practices with IEC 62304, ISO 14971 and ISO 13485, shaping design inputs, verification, validation and risk controls.

You’ll work within Engineering and report to Legal & Regulatory Affairs, collaborating with auditors and product teams to maintain compliant software releases and robust documentation.