Senior Systems Engineer, Medical Devices

Halcyon Knights Pty Ltd; Western Australia; On-site; AUD 140,000 - 150,000; Full time

Job summary

Halcyon Knights Pty Ltd in Perth, WA is seeking a Senior Systems Engineer for a 12-month contract in medical devices. You will lead cross-disciplinary system integration across hardware, software, firmware and regulation, delivering complete, traceable design evidence for regulatory submissions.

The role emphasizes hands-on delivery across the full product lifecycle with no direct reports, focusing on requirements, architecture, interfaces and testability within a regulated environment.

Qualifications

• Seven+ years in systems engineering or multidisciplinary product development.
• Hands-on experience developing regulated medical devices.
• Experience taking a medical product through later development stages, verification and regulatory submission.
• Strong requirements engineering, system architecture, interface definition and traceability.
• Understanding of mechanical, electronic, firmware and software interactions.
• System integration, verification, validation and root-cause analysis.

Responsibilities

• Developing and maintaining system requirements, architecture, interfaces and technical documentation.
• Translating clinical, product and regulatory needs into engineering requirements.
• Coordinating integration across mechanical, electronic, firmware and software components.
• Planning and supporting system integration, verification and validation activities.
• Maintaining traceability and supporting risk-management activities.
• Investigating complex system-level issues and identifying root causes.
• Contributing to design reviews and technical decision-making.
• Producing evidence and documentation for regulatory submissions.
• Working with engineering, manufacturing, clinical, quality and regulatory teams.

Skills

Regulatory systems

Systems engineering

Requirements engineering

Traceability

Hardware-software-firmware

Root-cause analysis

Medical-device standards

Regulatory submissions

Job description

Halcyon Knights Pty Ltd in Perth, WA is seeking a Senior Systems Engineer for a 12-month contract in medical devices. You will lead cross-disciplinary system integration across hardware, software, firmware and regulation, delivering complete, traceable design evidence for regulatory submissions.

The role emphasizes hands-on delivery across the full product lifecycle with no direct reports, focusing on requirements, architecture, interfaces and testability within a regulated environment.