Listed 3 weeks ago
Principle Software Engineer - Medical Devices
OnQ Recruitment
Engineering - Software
- Location
- Melbourne, VIC
- Type
- Full-time
About the role
An exciting opportunity exists for an experienced Software 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 critical part in shaping the future of its software platforms and engineering capability.
This is a hands-on leadership role where you will combine technical expertise, architectural decision-making, mentoring, and regulatory compliance knowledge to guide the development of complex medical device software systems. You will work closely with multidisciplinary engineering teams and external technology partners while helping drive the company's next-generation product platform.
About the Role
Reporting to the CTO, you will take ownership of software engineering across the entire product ecosystem, spanning embedded software, firmware, application software, cybersecurity considerations, and system integration. You will provide technical leadership to a growing software team while remaining actively involved in software design and development.
Key responsibilities include:
- Leading software architecture decisions across embedded and application software platforms.
- Designing and developing robust, scalable, and maintainable software solutions for regulated medical devices.
- Driving software development activities across both new product development and existing product enhancement programs.
- Ensuring compliance with medical device regulatory standards and software quality requirements.
- Collaborating with Systems, Electronics, Mechanical, Manufacturing, Quality, Regulatory and Clinical teams.
- Leading code reviews, technical reviews, software verification and validation activities.
- Supporting regulatory submissions, audits, and compliance activities.
- Identifying and implementing continuous improvements to software engineering processes, tools, and practices.
- Contributing to strategic technology decisions for future product platforms.
To be considered for this role, you will have the following skills and qualifications:
- A degree in Software Engineering, Computer Engineering, Computer Science, Electronics Engineering or a related discipline.
- 10+ years' experience developing software for medical devices.
- Strong expertise in C/C++ software development.
- Extensive experience with embedded systems, embedded Linux, RTOS environments and hardware-software integration.
- A strong understanding of software architecture, systems integration, communications protocols and real-time systems.
- Knowledge of IEC 62304, ISO 14971, ISO 13485 or comparable regulatory frameworks.
- Experience leading software teams, mentoring engineers and driving technical excellence.
- Experience with FPGA-based systems, ARM microcontrollers,
- Excellent stakeholder engagement and cross-functional communication skills.
