Senior Systems Engineer - Medical Device & Regulatory Leader

On Q Recruitment; Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

On Q Recruitment partners with a growing Australian medical technology company to appoint an experienced Systems Engineer who will drive the development of imaging and diagnostic platforms from concept through to commercial deployment.

You will report to the CTO and lead across software, electronics, optics, mechanical engineering, quality and regulatory functions, shaping requirements, architecture, risk management and system verification.

Qualifications

• Significant experience developing complex medical device products.
• Strong knowledge of Design Controls and systems engineering principles.
• Experience with risk management and ISO 14971.
• Experience leading multidisciplinary engineering projects.
• Understanding of FDA regulatory requirements.

Responsibilities

• Lead systems engineering activities across the full product lifecycle.
• Define and manage system requirements, architecture, interfaces, and traceability.
• Drive verification and validation to meet regulatory and customer requirements.
• Support FDA submissions and broader regulatory approval activities.
• Ensure compliance with IEC 62304, IEC 60601, ISO 14971 and ISO 13485.
• Lead risk management activities throughout the product lifecycle.
• Collaborate with Software, Electronics, Mechanical, Manufacturing, Quality and Regulatory teams.
• Provide technical leadership and mentoring across disciplines.
• Drive continuous improvement of systems engineering processes.
• Support strategic technology decisions for future platforms.
• Work with external development partners and suppliers.

Skills

Regulatory affairs experience

Requirements management

Risk management

Cross-functional leadership

Systems thinking

Education

Bachelor's degree in Systems Engineering

Biomedical Engineering

Electronics Engineering

Software Engineering

Mechanical Engineering

Job description

On Q Recruitment partners with a growing Australian medical technology company to appoint an experienced Systems Engineer who will drive the development of imaging and diagnostic platforms from concept through to commercial deployment.

You will report to the CTO and lead across software, electronics, optics, mechanical engineering, quality and regulatory functions, shaping requirements, architecture, risk management and system verification.