Senior Software Engineer

1 week ago

Sydney, New South Wales, Australia beBeeSoftwareDeveloper Full time $120,000 - $130,000

**Key Role in Software Development for Regulated Diagnostic Instruments**

Job Overview

This is a pivotal position in designing, developing, testing and maintaining software for regulated diagnostic instruments and platforms.

The successful candidate will be responsible for the design, development and implementation of software solutions in accordance with medical device standards.

  • Design and develop software for IVD instruments including embedded, desktop or cloud-based applications.
  • Implement software in compliance with IEC 62304, ISO 13485 and other relevant regulatory standards.
  • Write clean, efficient and well-documented code using languages such as C#, .Net, C++.

Key Responsibilities:

Software Design and Development

The ideal candidate will have experience in software design and development, with a strong understanding of medical device standards and regulations.

Responsibilities include:

  • 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.

Required Skills and Qualifications

Education and Experience

The following qualifications and experience are required for this position:

  • 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 IVD, medical device, pharma etc.
  • Familiarity with ISO 14971, IEC 62304, ISO 13485 and FDA.
  • Proficiency in one or more of the following C#, .NET, C++.

Desirable Qualifications

Additional Skills

The following skills are desirable but not essential:

  • 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 e.g. FDA premarket guidance.

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