SaMD Design Quality & Compliance Engineer | Hybrid + Equity

heidihealth.com.au; Sydney; Hybrid; AUD 170,000 - 210,000; Full time

Benefits offered by this job

Learning & development budget

Health and wellness allowance

Home office budget

Paid parental leave 26 weeks

Secondary parental leave 18 weeks

Fertility support up to $10,000

Work from anywhere 4 weeks per year

Equity

Job summary

Heidi seeks a Design Quality & Compliance Engineer in Sydney to join our mission of safer, smarter healthcare. You will anchor regulatory alignment for agile software development and ensure SaMD practices meet global standards.

Reporting to Legal & Regulatory Affairs and collaborating with Engineering, you will implement IEC 62304, ISO 14971, ISO 13485 across design inputs, verification, validation and risk controls, enabling rapid yet compliant releases.

Qualifications

• SaMD or regulated healthtech experience in a startup or scale-up.
• Strong working knowledge of IEC 62304, ISO 14971, and ISO 27001 and the ability to apply them practically.
• Technical security understanding, including cloud security, access control, network security, and secure software development lifecycle.
• Proactive, detail-oriented with the ability to drive tasks to completion in a fast-paced, high-growth environment.
• Collaboration and communication skills to work with engineers, product teams, auditors, and customers.
• Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline 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 for engineering teams.

Skills

SaMD experience

IEC 62304

ISO 14971

ISO 27001

Cloud security

Regulatory collaboration

Analytical mindset

Education

Bachelor’s degree or higher (relevant field)

Job description

Heidi seeks a Design Quality & Compliance Engineer in Sydney to join our mission of safer, smarter healthcare. You will anchor regulatory alignment for agile software development and ensure SaMD practices meet global standards.

Reporting to Legal & Regulatory Affairs and collaborating with Engineering, you will implement IEC 62304, ISO 14971, ISO 13485 across design inputs, verification, validation and risk controls, enabling rapid yet compliant releases.