Principle Software Engineer - Medical Devices
On Q Recruitment
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Zusammenfassung
On Q Recruitment is seeking a Principle Software Engineer for Medical Devices in Australia. You will lead architectural decisions across embedded and application software, mentor a growing team, and ensure regulatory compliance for complex medical device software systems.
Reporting to the CTO, you will own the software engineering discipline across the product ecosystem, drive ongoing product development and improvements, and collaborate with cross-functional teams to deliver safe, scalable
Qualifikationen
- 10+ years' experience developing software for medical devices.
- Experience with embedded Linux, RTOS, and hardware-software integration.
- Strong knowledge of software architecture, systems integration, and real-time systems.
- Familiarity with IEC 62304, ISO 14971, ISO 13485 or equivalent regulatory standards.
- Proven experience leading software teams and mentoring engineers.
- Experience with FPGA-based systems and ARM microcontrollers.
- Excellent stakeholder engagement and cross-functional communication skills.
Aufgaben
- Lead software architecture decisions across embedded and application software platforms.
- Design robust, scalable, and maintainable software for regulated medical devices.
- Drive software development across new product development and enhancements.
- Ensure compliance with medical device regulatory standards and software quality requirements.
- Collaborate with Systems, Electronics, Mechanical, Manufacturing, Quality, Regulatory and Clinical teams.
- Lead code reviews, software verification and validation activities.
- Support regulatory submissions, audits and compliance activities.
- Identify and implement continuous improvements to software processes and tools.
- Contribute to strategic technology decisions for future product platforms.
Kenntnisse
Ausbildung
Jobbeschreibung
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.
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.
- 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.
- 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.
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.
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.
- 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.
This opportunity will suit a senior professional who enjoys solving complex technical challenges whilst helping build products that can make a meaningful difference to patient outcomes.
- Newly created permanent position within a medical technology company
- Play a key role in the development of next-generation products
- Opportunity to mentor a growing software engineering team
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