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Job Description
Structured overview of role & requirementsAbout This Role
Develop, document, and maintain complex software applications in C, C++, C# with .NET for embedded ophthalmic surgical and medical devices.
Ensure compliance with IEC 62304 and FDA-regulated medical device software development standards throughout the software lifecycle phases.
Design and implement automated tests, participate in code reviews, risk assessments, and mentor junior engineers in an Agile/Scrum setting.
Minimum Requirements
5+ years work experience developing safety-critical software in the medical device industry.
Proficiency in C, C++, C# development with .NET, including Windows development and multi-threading.
University degree in Computer Science, Engineering, or related discipline with at least 5 years work experience.
Familiarity with IEC 62304, FDA medical device software lifecycle processes, and software development standards for safety-critical systems.
Ideal Candidate Profile
Experienced with embedded software development for FDA-regulated medical device products, especially in ophthalmic devices.
Skillful in software architecture, object-oriented design patterns, and developing maintainable, reusable code with advanced design principles.
Comfortable working within Agile/Scrum teams, self-driven to research technical issues and implement innovative solutions.