At a Glance
- Tasks: Lead systems engineering for innovative medical devices from concept to commercialisation.
- Company: Growing Australian medical tech company focused on imaging and diagnostics.
- Benefits: Competitive salary, career growth, and a chance to impact healthcare technology.
- Other info: Work in a dynamic environment with a focus on collaboration and continuous improvement.
- Why this job: Be a key player in developing life-changing medical technologies and ensuring regulatory compliance.
- Qualifications: Degree in relevant engineering field and experience in medical device development.
The predicted salary is between 90000 - 110000 $ per year.
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.
Principal Systems Engineer in Melbourne employer: On Q Recruitment
On Q Recruitment is an excellent employer, offering a dynamic work culture that values innovation and collaboration in the heart of Canberra. Employees benefit from professional growth opportunities, a supportive environment, and the chance to contribute to meaningful projects that enhance public transparency. With a focus on work-life balance and employee well-being, this role provides a unique opportunity to make a significant impact while enjoying the vibrant lifestyle that Canberra has to offer.
