Software Developer

R-Biopharm AG

Sydney

On-site

AUD 120,000 - 130,000

Full time

14 days+

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Job summary

A leading company in the In Vitro Diagnostics (IVD) space is seeking a highly skilled Software Developer to join their innovative team. This pivotal role involves designing, developing, testing, and maintaining software for regulated diagnostic instruments and platforms. The ideal candidate will have strong experience in software development, particularly in a regulated environment, and proficiency in languages such as C#, .NET, and C++. The position offers a competitive salary and the opportunity to collaborate with a diverse team to improve diagnostic accuracy and patient outcomes.

Qualifications

5+ years of professional experience in software development, preferably in a regulated environment.
Familiarity with ISO 14971, IEC62304, ISO13485 and FDA.
Experience developing software for automated laboratory systems or point-of-care diagnostics.

Responsibilities

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.
Support verification and validation activities, including unit testing and system testing.

Skills

Problem-solving

Attention to detail

Education

Bachelor’s or Master’s degree in Computer Science, Software Engineering, or a related field

Tools

.NET

C++

Job description

This range is provided by R-Biopharm AG. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

A$120,000.00/yr - A$130,000.00/yr

Direct message the job poster from R-Biopharm AG

Recruitment Consultant @ AusDiagnostics | Human Resources with Law

We are seeking a highly skilled and motivated Software Developer to join our innovative team in the In Vitro Diagnostics (IVD) space. This role is pivotal in designing, developing, testing, and maintaining software for regulated diagnostic instruments and platforms, in accordance with medical device standards. You'll collaborate with scientists, engineers, and regulatory experts to create robust, scalable, and compliant solutions that improve diagnostic accuracy and patient outcomes.

Key Responsibilities:

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++.
Collaborate with cross-functional teams (e.g., hardware, assay development, QA/RA) 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).
Stay up to date with industry trends, standards, and best practices in medical device software development.

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 (IVD, medical device, pharma, etc.).
Familiarity with ISO 14971, IEC62304, ISO13485 and FDA.
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 (e.g., FDA premarket guidance).

Seniority level

Seniority level
Associate

Employment type

Employment type
Full-time

Job function

Job function
Research
Industries
Biotechnology

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