Principal Systems Engineer

OnQ 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

An exciting opportunity exists for an experienced Systems Engineer to join a growing Australian medical technology company developing innovative imaging and diagnostic platforms.

As the organisation transitions from advanced R&D into commercialisation and global regulatory approvals, this role will play a pivotal part in strengthening systems engineering capability, supporting FDA submissions, and ensuring products are developed in accordance with global medical device regulations.

This is a highly visible technical leadership position where you will work across software, electronics, optics, mechanical engineering, quality and regulatory functions to guide the development of sophisticated medical device systems from concept through to commercial deployment.

About the Role

Reporting to the CTO, you will provide Systems Engineering leadership across the organisation's product portfolio, ensuring robust engineering processes, regulatory compliance, and successful product integration. You will become a key technical authority responsible for driving requirements management, verification and validation activities, risk management, and system architecture decisions.

Key responsibilities include:

• Leading systems engineering activities across the full product development lifecycle.
• Defining and managing system requirements, architecture, interfaces, and traceability.
• Driving verification and validation activities to ensure products meet customer, clinical and regulatory requirements.
• Supporting FDA submissions and broader regulatory approval activities.
• Ensuring compliance with relevant medical device standards, including IEC 62304, IEC 60601, ISO 14971 and ISO 13485.
• Leading risk management activities throughout the product lifecycle.
• Collaborating with Software, Electronics, Mechanical, Manufacturing, Quality and Regulatory teams to deliver integrated product solutions.
• Providing technical leadership and mentoring engineers across multiple disciplines.
• Driving continuous improvement initiatives across systems engineering processes and development methodologies.
• Supporting strategic technology decisions for future product platforms and product enhancements.
• Working closely with external development partners, suppliers and key technical stakeholders.

About You

• A degree in Systems Engineering, Biomedical Engineering, Electronics Engineering, Software Engineering, Mechanical Engineering or a related discipline.
• Significant experience developing complex products within the medical device industry and a strong understanding of Design Controls.
• Strong knowledge of systems engineering principles, requirements management, verification and validation.
• Experience with risk management frameworks and standards including ISO 14971.
• Experience leading multidisciplinary engineering projects and influencing stakeholders at all levels.
• Strong problem-solving, communication and stakeholder management skills.
• An understanding of FDA regulatory requirements

This opportunity will suit a senior engineering professional who enjoys working at the intersection of technology, product development and regulatory compliance. This role is based 4 days per week in the office.