Design Quality Engineer

Heidi Health
Sydney, Melbourne
Workplace: HybridFull timeFunction: QA, Test & Release EngineeringSkills: ["Proactive","Detail-oriented","Communication","Collaboration","Quality-minded"]

Own the design-quality and compliance processes that help engineering teams build world-class, regulated software faster and safer. Partner with engineering and product to translate IEC 62304, ISO 14971, and ISO 13485 into traceable requirements, risk controls, verification and validation activities, and technical documentation. Support audits, champion evidence-based development practices, and ensure each release meets regulatory scrutiny in a hybrid agile environment.

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Heidi Health
Heidi Health
17 hours ago

Design Quality Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 7 hours agoStatus: Live

Job Summary

Own the design-quality and compliance processes that help engineering teams build world-class, regulated software faster and safer. Partner with engineering and product to translate IEC 62304, ISO 14971, and ISO 13485 into traceable requirements, risk controls, verification and validation activities, and technical documentation. Support audits, champion evidence-based development practices, and ensure each release meets regulatory scrutiny in a hybrid agile environment.
Location: Sydney, Melbourne
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Implement and continuously improve 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 are defined, documented, and traceable.
  • •Support 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 by translating IEC/ISO standards into clear, actionable processes for engineering teams.

Pay and Benefits

Perks:Learning BudgetHealth InsuranceWellness StipendHome OfficeParental LeaveFertility SupportRemote WorkEquity

Key Requirements

  • •Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment.
  • •Strong working knowledge of IEC 62304, ISO 14971, and ISO 13485, with the ability to apply them in practical ways.
  • •Understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.
  • •Ability to translate complex IEC/ISO standards into clear, developer-friendly processes and drive tasks to completion.
  • •Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline (a plus).
Experience:HealthtechRegulated softwareSaMDStart-up environmentScale-up environment
Skills:ProactiveDetail-orientedCommunicationCollaborationQuality-minded
Tech Stack:IEC 62304ISO 14971ISO 13485ISO 27001SaMDCloud securityAccess controlNetwork securitySecure software development lifecycle

Company Brief

Heidi Health
Builds an AI medical scribe and clinical productivity platform that automates documentation, form-filling, and task management to expand clinician capacity across hospitals, GP clinics and specialist services worldwide.
Industry: HealthTech
Company Size: Medium (51 to 250 employees)
Growth: Scaleup
Valuation: USD 250M to 500M
Funding: Series B
Headquarters: Melbourne, Australia
Founded: 2019
Glassdoor
Glassdoor: 4.7
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