Heidi Health

Design Quality & Compliance Engineer – SaMD, Information Security

Heidi Health

full-time

Posted on:

Location Type: Hybrid

Location: Sydney • 🇦🇺 Australia

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Job Level

Mid-LevelSenior

Tech Stack

Cloud

About the role

  • Drive Medical Device Design Control Processes
  • Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with international standards.
  • 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 Notified Body audits, with a focus on Design and Development aspects.
  • Champion compliance in software development by translating complex and opaque standards into clear, actionable processes that engineering teams can follow.
  • Support and coordinate external security and compliance audits.
  • Attend calls and liaise directly with external auditors and stakeholders to ensure a smooth, efficient process and successful completion of all audit activities.
  • Take the lead on completing detailed security questionnaires, focusing on all technical aspects of the responses.
  • Collaborate across engineering, product, and legal teams to gather required evidence for audits and questionnaires, and participate in calls to provide technical clarifications when needed.
  • Aid in the creation and maintenance of technical documentation, policies, and control mappings related to security and compliance.

Requirements

  • SaMD Experience: Prior experience working on Software as a Medical Device (SaMD) or other regulated healthtech products, ideally in a start-up or scale-up environment.
  • Standards: Strong working knowledge of standards such as IEC 62304, ISO 13485, ISO 14971, and ISO 27001, and the ability to apply these in practical, developer-friendly ways.
  • Technical Skills: A solid understanding of technical security domains, including cloud security, access control, network security, and secure software development lifecycles.
  • Proactive & Detail-Oriented: A commitment to quality and the ability to drive tasks to completion in a fast-paced, high-growth environment.
  • Collaboration & Communication: Excellent communication skills, enabling you to work effectively with internal teams (engineers, product) and manage external partners (auditors, customers).
  • A Bachelor’s degree or higher in a relevant scientific, engineering, regulatory, legal, or governance discipline is a plus.
Benefits
  • Flexible work with a hybrid environment.
  • Additional paid day off for your birthday and wellness days.
  • Discounted corporate gym memberships.
  • A generous personal development budget of $500 per annum.
  • Learn from some of the best engineers and creatives, joining a diverse team.
  • Become an owner, with shares (equity) in the company, if Heidi wins, we all win.
  • The rare chance to create a global impact as you immerse yourself in one of Australia’s leading healthtech startups.
  • If you have an impact quickly, the opportunity to fast track your startup career!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
design control processestechnical documentationrisk managementverification and validationcloud securityaccess controlnetwork securitysecure software development lifecycleSaMD experienceISO 13485
Soft skills
proactivedetail-orientedcollaborationcommunicationcommitment to quality