Job Title: Software Development Engineer in Test (SDET) - C++
Job Description:
Top 3 Must haves:
1. Proficiency in C++ programming language
2. Strong understanding of object-oriented programming (OOP) principles and software design patterns.
3. hands-on experience developing and testing software for medical devices, with a strong focus on compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
Job Summary
We are seeking a skilled C++ Developer to join our team in the medical device domain. The ideal candidate will have hands-on experience developing and testing software for medical devices, with a strong focus on compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304). This role involves working closely with cross-functional teams to develop, validate, and maintain high-quality, reliable software for class II and III medical devices.
Key Responsibilities
Software Development:
Design, develop, and maintain robust software infrastructure solutions using C++ for medical devices.
Implement features and functionality to support diagnostic, monitoring, and therapeutic medical systems.
Regulatory Compliance:
Ensure adherence to medical device standards such as IEC 62304, ISO 14971, and FDA guidelines for software development and validation.
Document code, design, and validation processes to meet regulatory requirements.
Testing and Validation:
Develop and execute unit tests, integration tests, and system-level tests.
Conduct requirement validation, test case development, and test coverage analysis using shift-left techniques.
Perform automated and manual testing to ensure device safety and efficacy.
Collaboration:
Work closely with system architects, quality assurance teams, and regulatory professionals.
Provide support during design reviews, audits, and regulatory submissions.
Continuous Improvement:
Optimize existing software for performance, scalability, and maintainability.
Stay updated on emerging trends and best practices in software development for medical devices.
Qualifications
Required Skills:
Proficiency in C++ programming languages.
Strong understanding of object-oriented programming (OOP) principles and software design patterns.
Experience with software development lifecycle (SDLC) in regulated environments.
Knowledge of IEC 62304 and other relevant medical device software standards.
Familiarity with tools like Git, JIRA, Azure DevOps, or similar for version control and project management.
Preferred Skills:
Experience with software and system-level testing for Class II and Class III medical devices.
Knowledge of communication protocols such as CAN, USB, BLE, or TCP/IP.
Education and Experience:
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or a related field.
Minimum 5-7 years of experience in software development for medical devices or a regulated domain.
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