IT Professional

1 week ago

Sydney, New South Wales, Australia beBeeSoftware Full time $120,000 - $130,000
Software Development Opportunities">

This role is pivotal in designing, developing, testing, and maintaining software for regulated diagnostic instruments and platforms, in accordance with medical device standards.

You will collaborate with scientists, engineers, and regulatory experts to create robust, scalable, and compliant solutions that improve diagnostic accuracy and patient outcomes.

The ideal candidate will possess a strong foundation in software development, preferably in a regulated environment, and be familiar with ISO 14971, IEC 62304, and ISO 13485.

Key Responsibilities:

  • Design and develop software for IVD instruments, including embedded, desktop, or cloud-based applications.
  • Implement software in compliance with relevant regulatory standards.
  • Write clean, efficient, and well-documented code using languages such as C#, .Net, C++.
  • Collaborate with cross-functional teams to define software requirements and system specifications.
  • Participate in code reviews, software risk assessments, and hazard analysis.
  • Support verification and validation activities, including unit testing, system testing, and documentation.
  • Troubleshoot issues and implement corrective actions throughout the software lifecycle.
  • Contribute to technical documentation, including design history files (DHF) and software development plans (SDP).

Required Qualifications & Experience:

  • Bachelor's or Master's degree in Computer Science, Software Engineering, or a related field.
  • 5+ years of professional experience in software development, preferably in a regulated environment.
  • Familiarity with ISO 14971, IEC 62304, and ISO 13485.
  • Proficiency in one or more of the following: C#, .NET, C++.
  • Strong problem-solving skills and attention to detail.
  • Experience developing software for automated laboratory systems or point-of-care diagnostics.
  • Understanding of molecular diagnostics, immunoassays, or clinical workflows.
  • Knowledge of cybersecurity requirements for medical devices.
Seniority Level:

Associate

Employment Type:

Full-time

Job Function:

Research

Industries:

Biotechnology

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