SaMD Design Quality & Compliance Engineer

Heidi Health Corp.; City of Melbourne; Hybrid; AUD 140,000 - 180,000; Full time

Benefits offered by this job

Learning and development budget

Health and wellness allowance

Home office budget

Parental leave (26 weeks)

Fertility support

Work from anywhere (4 weeks/year)

Equity

Job summary

Heidi is building world‑class healthcare AI with a regulatory‑savvy Design Quality & Compliance Engineer. You will integrate with Legal & Regulatory Affairs and Engineering to ensure software design aligns with global medical device standards.

You’ll implement IEC 62304, ISO 14971, ISO 13485 within an agile context, shaping how design inputs, verification, validation and risk controls are captured and evidenced.

Qualifications

• SaMD experience in regulated healthtech environments, preferably startup/scale‑up.
• Strong working knowledge of IEC 62304, ISO 14971, ISO 27001 and applying them practically.
• Solid understanding of cloud security, access control, network security, and secure SDLC.
• Proactive and detail‑oriented with ability to drive tasks to completion in a fast‑paced setting.
• Excellent communication to work with engineers, product teams, auditors, and customers.

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.
• Ensure requirements, risk controls, verification, and validation are defined, documented, and traceable.
• Maintain technical documentation including requirements specs, risk files, verification reports, and change records.
• Support external ISO 13485 and Notified Body audits focusing on design and development aspects.
• Translate IEC/ISO standards into clear, actionable software development processes for engineering teams.

Skills

SaMD Experience

Regulatory standards

Security foundations

Detail-oriented

Collaboration & communication

Education

Bachelor’s degree or higher in a relevant field

Job description

Heidi is building world‑class healthcare AI with a regulatory‑savvy Design Quality & Compliance Engineer. You will integrate with Legal & Regulatory Affairs and Engineering to ensure software design aligns with global medical device standards.

You’ll implement IEC 62304, ISO 14971, ISO 13485 within an agile context, shaping how design inputs, verification, validation and risk controls are captured and evidenced.