Systems Engineer
Universal Biosensors, Australia

Universal Biosensors (UBI) is a world leading, publicly listed Australian company (ASX:UBI) which develops, manufactures and sells biosensors for use in several industries around the world. Our biosensor technology has been used in more than 10 billion measurements for blood glucose monitoring and blood coagulation in diabetes and coagulation patients worldwide. Recently, we have pivoted our technology into the wine industry with our global launch of SENTIA earlier this year. In addition, we continue to develop new applications for our technology within human health, veterinarian and food amp; agriculture.

We are looking for a focused and driven individual to expand the Device Development team at our HQ office in Melbourne as a Systems Engineer. This position is a key player in the team, spearheading the systematic conversion of NPI (New Product Introduction) requirements into total system solutions aligned to project cost amp; timeline constraints.

The role will consist of (but not limited to) the following activities for our biosensor device (integrated with embedded software):-

• Develop and document Vamp;V requirements and protocols
• Create and maintain system documentation suite for each product, inc. URS, FS, SRS, UI and trace matrix.
• Document and perform system release testing
• Assist with Usability Testing and Safety Compliance Testing
• Participates in SRA throughout NPI development and post-launch design changes.
• Provides input to project management in creation of project timelines

Requirements

In addition to Tertiary qualification in Systems Engineering, Electronics amp; Communications Engineering, or Computer Science (or similar), the following skills and qualifications are considered necessary in this role:

• Minimum 4 years’ experience in a GMP/regulated environment (e.g. automotive, aeronautical, medical), esp. in systems integration, black/white box testing
• Strong technical, analytical skills to support sound problem solving and design processes
• Able to create specifications from product brief
• Strong practical experience in generating product documentation with version controls, e.g. protocols, specs, etc.
• Excellent time management skills and ability to work independently or within a team
• Self-starter who sets challenging goals to improve performance
• Attention to detail and good communication skills.
• Well-articulated with ability to present complex information in a simple and meaningful way to all levels of management

• Sound working knowledge of at least one: ISO 9001, ISO 13485 and FDA CFR Part 820 QMS requirements

Benefits

The successful candidate will be given opportunities in the following:-

• Employee Assistance Program (EAP)
• Flu Vaccinations
• Training amp; Development
• Novated Leasing

This is a rare career opportunity for someone who has a keen interest in the biotech space! If you're ready to do what it takes to reach the goal, please apply with your current CV, highlighting your relevant skill sets and experience!

Only apply if you're an Australian citizen/Permanent Resident or holding a valid visa with full working rights in Australia.

Job Rewards and Benefits