Design Quality Engineer

Heidi Health
London
Workplace: HybridFull timeFunction: QA, Test & Release EngineeringEducation: bachelorsSkills: ["Communication","Collaboration","Detail-oriented","Proactive"]

Ensure Heidi’s agile software development activities meet global medical device and information security requirements. You’ll implement and continuously improve design control processes across the software lifecycle, translating standards like IEC 62304, ISO 14971, and ISO 13485 into practical workflows. Partner with engineering and product to make requirements, risk controls, verification, validation, and documentation traceable, supporting audits and regulatory scrutiny.

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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

Ensure Heidi’s agile software development activities meet global medical device and information security requirements. You’ll implement and continuously improve design control processes across the software lifecycle, translating standards like IEC 62304, ISO 14971, and ISO 13485 into practical workflows. Partner with engineering and product to make requirements, risk controls, verification, validation, and documentation traceable, supporting audits and regulatory scrutiny.
Location: London
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Lead implementation and continuous improvement of design control processes across the software lifecycle aligned with IEC 62304, ISO 14971, and ISO 13485.
  • •Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation are clearly defined, documented, and traceable.
  • •Support 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 focused on design and development.
  • •Translate complex IEC/ISO standards into clear, actionable processes that engineering teams can follow.

Pay and Benefits

Perks:Private MedicalDentalHealth InsuranceWellness StipendHome OfficeLearning BudgetParental LeaveFertility SupportWork FromRecharge DaysClinical Leave

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 27001, with the ability to apply them in practical ways for engineering teams.
  • •A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.
  • •Commitment to quality and driving tasks to completion in a fast-paced, high-growth environment.
  • •A bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.
Experience:HealthtechRegulated medical devicesSaMD
Education:Bachelor's
Skills:CommunicationCollaborationDetail-orientedProactive
Tech Stack:IEC 62304ISO 14971ISO 13485ISO 27001SaMD

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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