Design Quality Engineer
Heidi Health · Sydney · AU
Posted 60+ days ago
Regulatory Affairs
Hybrid
Not yet analysed
Demand85
Career growth80
Healthcare fit72
Remote potential60
5-year outlook
Health tech regulatory and quality roles are in high demand, with salaries typically competitive for experienced professionals. Expect growth as medical device software regulations evolve, but exact figures depend on location and seniority.
Clinical license
Not required
Applicant reach
moderate
Seniority
mid
Employment type
full-time
Date found
2026-08-26
Intelligence details
Why this is worth applying to
Clinicians with a strong interest in health tech, regulatory affairs, and quality systems should consider this role. It offers a chance to shape compliant AI tools that directly impact clinical workflows, but requires significant regulatory/engineering experience.
Who should apply
Doctors, nurses, or allied health professionals with prior experience in quality improvement, clinical informatics, or regulatory affairs, and a passion for medical device software compliance.
CV angle
Highlight clinical experience as evidence of understanding user needs and patient safety. Emphasize any involvement in process improvement, protocol development, or technology adoption. Frame clinical documentation and workflow knowledge as a foundation for design control and risk management.
Skills to highlight
- Regulatory standards knowledge
- Risk management
- Design control
- Cross-functional collaboration
- Technical documentation
- Agile development
- Clinical workflow understanding
- Quality systems
Role summary
A Design Quality Engineer at Heidi Health ensures their AI scribe software complies with global medical device standards (IEC 62304, ISO 14971, ISO 13485) by implementing design controls and supporting audits, bridging engineering and regulatory teams.
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