Principal Systems Engineer

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

Job summary

On Q Recruitment Pty Ltd in Melbourne is seeking an experienced Systems Engineer to lead our medical technology product portfolio, ensuring robust engineering processes, regulatory compliance, and seamless product integration.

You will drive requirements management, verification and validation, risk management, and system architecture decisions, collaborating with software, electronics, mechanical, and regulatory teams, mentoring engineers, and guiding FDA submissions.

Qualifications

• A degree in Systems Engineering or related field.
• Significant medical device product development experience and Design Controls knowledge.
• Strong knowledge of systems engineering principles, requirements management, verification and validation.
• Experience with ISO 14971 risk management.
• Experience leading multidisciplinary engineering projects and stakeholder management.
• Strong problem-solving and communication skills, with FDA regulatory understanding.

Responsibilities

• Lead systems engineering across the full product lifecycle.
• Define and manage system requirements, architecture, interfaces and traceability.
• Drive verification and validation to meet regulatory needs.
• Support FDA submissions and related regulatory activities.
• Ensure compliance with IEC 62304, IEC 60601, ISO 14971 and ISO 13485.
• Lead risk management across 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

Systems engineering

Regulatory compliance

Requirements management

Risk management

Stakeholder management

Leadership

Education

Systems Engineering degree

Biomedical Engineering degree

Tools

IEC 62304 knowledge

IEC 60601 knowledge

ISO 14971 knowledge

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.

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

To be considered for this role, you will have the following skills and qualifications:

• 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. For a confidential conversation about this role, please email @onqrecruitment.com.au.