Systems Engineer - Melbourne, Victoria

Job summary

The Company is a global leader in microscopic imaging, with patented technologies enabling in vivo imaging of tissues across a wide range of surgical, pathology and life sciences applications. You will provide systems engineering expertise to a cross-functional team working on an R&D project for the next-generation version of an existing device.

Responsibilities

• Perform systems engineering activities across the full product lifecycle for medical devices.
• Develop test protocols and execute integration, verification, and validation testing.
• Define and manage systems requirements in collaboration with other project members.
• Engage stakeholders to conduct usability studies and define clinical and technical use cases.
• Perform risk assessments and regression analyses to support product safety and performance.
• Manage configuration and change control processes for released products.
• Prepare high-quality documentation to support regulatory submissions.

Qualifications

• Bachelor's degree in biomedical engineering, systems engineering, or a related discipline.
• 5+ years of experience as a graduate engineer working on medical devices and technologies.
• Experience in medical device design, preferably in Class II or Class III device(s).
• Experience in designing, conducting and documenting verification and validation of designs.
• Knowledge of international standards relevant to medical device development.
• Experience in multi-disciplinary projects involving electronics, software and optics
• Excellent written and verbal communication skills.

Job description