SaMD Design & Compliance Engineer

Heidi; Sydney; Hybrid; AUD 150,000 - 190,000; Full time

Benefits offered by this job

Learning & development budget

Health and wellness allowance

Home office budget

Parental leave (paid)

Fertility support

Work from anywhere (4 weeks/year)

Equity

Job summary

Heidi is seeking a Design Quality & Compliance Engineer to ensure our software design and development meet global medical device requirements. You will work with Engineering and the Legal & Regulatory Affairs team to implement IEC 62304, ISO 14971, and ISO 13485 within an agile environment.

You’ll drive design controls, maintain technical docs, support audits, and translate complex standards into practical processes for fast, safe releases that pass regulatory scrutiny.

Qualifications

• Experience on SaMD or regulated healthtech products.
• Strong working knowledge of IEC 62304, ISO 14971, ISO 27001.
• Translate complex IEC/ISO standards into actionable processes for engineers.

Responsibilities

• Lead the implementation of design control processes across the software lifecycle.
• Collaborate with engineers and product managers to ensure clear, traceable requirements and verifications.
• Maintain and review technical documentation (requirements, risk files, verification reports).
• Support external ISO 13485 audits and Notified Body activities.
• Champion regulatory compliance in agile software development.

Skills

SaMD Experience

Standards IEC 62304

ISO 14971

ISO 27001

Technical security

Collaboration & Communication

Education

Bachelor’s degree or higher in a relevant field

Job description

Heidi is seeking a Design Quality & Compliance Engineer to ensure our software design and development meet global medical device requirements. You will work with Engineering and the Legal & Regulatory Affairs team to implement IEC 62304, ISO 14971, and ISO 13485 within an agile environment.

You’ll drive design controls, maintain technical docs, support audits, and translate complex standards into practical processes for fast, safe releases that pass regulatory scrutiny.