Senior Systems Engineer - Medical Devices & Validation

ProFound People Pty Ltd; Perth; Hybrid; AUD 150,000 - 200,000; Full time

Job summary

ProFound People Pty Ltd in Perth, Australia, is seeking a Senior Systems Engineer to be the technical thread tying hardware, software, and production together for a medical device project. You will ensure design decisions, test results, and regulatory considerations align for a defensible approval file.

The role requires hands-on experience across systems, with a strong background in regulated medical devices, ISO standards, and FDA or equivalent approvals.

Qualifications

• 7+ years of full-time engineering experience, with substantial part in medical devices.
• Experience taking a complex product from concept through build, test, and handover to production.
• Familiarity with ISO 13485 and ISO 14971 and related product safety and software standards.
• Direct involvement in a product that gained FDA or equivalent regulatory approval.
• Senior, self-directed profile with broad remit and no direct reports.

Responsibilities

• Assemble and maintain the proof an approval body will review, linking tests to targets and user needs.
• Collaborate with end users, researchers, and product owners to set measurable targets for the product.
• Assess proposed design changes for impact across hardware, software, production, instructions for use, and approvals.
• Hands-on work with prototype and early production builds; decide contents, sequence, and readiness for testing.
• Maintain architecture documentation across electronics, firmware, software, and mechanical parts.
• Identify failure modes and safeguards, including misuse and third-party issues, ensuring testing covers them.
• Plan testing at all levels, set pass criteria, lead investigations of unexpected results.
• Manage a clean handover to production and partners, ensuring later changes are traceable.
• Facilitate cross-functional decisions while preserving specialists' ownership.
• Introduce lightweight engineering practices and mentor colleagues.

Skills

Broad technical grounding

Education

Engineering degree

Tools

SysML/MBSE

Jama/DOORS/Polarion

Job description

ProFound People Pty Ltd in Perth, Australia, is seeking a Senior Systems Engineer to be the technical thread tying hardware, software, and production together for a medical device project. You will ensure design decisions, test results, and regulatory considerations align for a defensible approval file.

The role requires hands-on experience across systems, with a strong background in regulated medical devices, ISO standards, and FDA or equivalent approvals.