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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 rangeA$120,000.00/yr - A$130,000.00/yrDirect message the job poster from R-Biopharm AGRecruitment Consultant @ AusDiagnostics | Human Resources with LawWe 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 & ExperienceBachelor''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 levelSeniority levelAssociateEmployment typeEmployment typeFull-timeJob functionJob functionResearchIndustriesBiotechnologyReferrals increase your chances of interviewing at R-Biopharm AG by 2xGet notified about new Software Engineer jobs in Mascot, New South Wales, Australia.Software Engineer, Early Career, NetSoftSydney, New South Wales, Australia 2 weeks ago2025 Software Development Graduate (AWS, Auckland,NZ), (0-2 Years, Entry-Level)Sydney, New South Wales, Australia 3 days agoNorth Sydney, New South Wales, Australia 2 hours agoSydney, New South Wales, Australia 2 weeks agoSoftware Development Graduate (2025, AWS)Sydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 4 days agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 3 weeks agoSoftware Engineer, Early Career, iOS, PhotosSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 3 days agoSydney, New South Wales, Australia 3 days agoIntern Software Engineer - Multiple RolesSydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 2 weeks agoSoftware Engineer (Python) - Data Platform (Open to remote across ANZ)Sydney, New South Wales, Australia 2 weeks agoSoftware Engineering Internship (Dec 2025 - March 2026)Sydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 3 months agoSydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 3 days agoSydney, New South Wales, Australia 3 weeks agoBackend Engineer (Java), Media Platform - Global Content and Discovery (open to remote across ANZ)Sydney, New South Wales, Australia 2 weeks ago2025 Australia Software Engineering InternshipSydney, New South Wales, Australia 2 hours agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 weeks agoMid-Level Software Engineer (2 Positions)Sydney, New South Wales, Australia 2 months agoEveleigh, New South Wales, Australia 6 days agoWe''re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr