About Navbit
Navbit is an Australian surgical technology innovator and manufacturer. We develop technologies which are used by orthopaedic surgeons in Australia and Japan; we have a history of working with large reputable distribution partners including Johnson & Johnson MedTech, and Smith & Nephew.
We currently have a small team of 13: made up of engineers, quality, regulatory, finance/commercial professionals; and we expect the team to grow in 2026 as we launch into new international markets.
Job Location
Navbit head office at Cicada Innovations /National Innovation Centre in the heart of the buzzing tech-precinct at South Eveleigh. Office is very conveniently located just a 2 minute' walk from Redfern station.
The Role
Director of Engineering
The Director Engineering is part of the senior management team - accountable for maintaining and advancing Navbit's medical device product portfolio through disciplined, compliant, and commercially driven engineering practices. This role ensures that existing electromechanical and software-based (SaMD) products remain robust, manufacturable, and compliant under ISO 13485 and associated standards. The Director leads a small team of engineers, providing technical direction and fostering cross-functional collaboration with Operations, Quality, and Regulatory Affairs.
The Director of Engineering is responsible for, and oversees the work of our external development partners - and contract manufacturers in Australia, Malaysia and China.
The position requires a pragmatic, roll-your sleeves-up leader who combines deep technical capability with management experience, driving engineering consistency, design control discipline, and supplier engagement. The role involves some travel to the sites of our contract manufacturers.
* Sustaining Engineering Leadership - Lead sustaining activities for existing electromechanical and software-based medical devices, ensuring that product specifications, documentation, and verification data remain current and compliant.
* Manage implementation of planned new design changes (e.g; addition of product accessories), these to enhance product or improve customer experiences and reporting (e.g using Bluetooth).
* Design and Development (D&D) Stewardship - Oversee specification maintenance, design updates, and verification of design changes under ISO 13485 and IEC 62304 frameworks.
* Ensure alignment with regulatory and commercial requirements.
* Manufacturing and Supply-Chain Interface - Liaise with internal and outsourced manufacturing partners to resolve design, process, and quality issues. Support tooling, jig, and test-equipment development to ensure repeatable build quality and device reliability.
* Quality and Compliance Focus - Ensure engineering activities adhere to Navbit's QMS and relevant standards (ISO 13485, ISO 14971, IEC, IEC Contribute to internal and external audits and maintain up-to-date technical documentation. Lead and support
* Nonconformance (NC) and Corrective and Preventive Action (CAPA) investigations, ensuring effective root-cause analysis, documentation, and implementation of preventive measures.
* AI and Software (SaMD) Support - Collaborate with software and data science teams to sustain algorithms, interfaces, and AI-enabled functionality. Liaise directly with
* Regulatory Affairs to ensure that AI features and software updates comply with evolving global regulatory requirements and that necessary regulatory filings, approvals, or change notifications can be successfully executed. Support software lifecycle maintenance and risk management documentation under IEC 62304 and ISO 14971.
* Cross-Functional Collaboration - Work closely with Operations, Quality, and Regulatory team to achieve design, compliance, and commercial objectives. Provide technical input to change control, risk management, and regulatory submissions.
* People Management and Mentoring - Manage and develop engineering staff, ensuring consistent performance, documentation quality, and alignment with business priorities.
* Build a culture of pragmatic problem-solving and accountability.
* Continuous Improvement - Drive initiatives to improve manufacturability, testability, and long-term reliability of Navbit devices. Promote disciplined engineering practices, knowledge retention, and continuous QMS improvement.
Required Qualifications
* Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, Mechatronics, or
* related discipline).
* Minimum of 7 years' experience in medical device or regulated-industry engineering,
* including at least 3 years in a leadership or supervisory capacity.
* Demonstrated experience in design and development, sustaining engineering, and
* specification management.
* Proven ability to liaise effectively with contract manufacturers and outsourced suppliers.
* Working knowledge of ISO 13485, ISO 14971, and IEC 62304 frameworks.
* Experience leading NC/CAPA investigations and implementing effective preventive
* actions.
* Experience supporting SaMD and understanding of AI-based software maintenance and
* regulatory pathways desirable.
* Strong communication, organization, and reporting skills.
* Practical, consistent, and deliberate leadership approach aligned with commercial
* priorities.