What are the responsibilities and job description for the Software Engineer in Test (C++) position at Signature IT World Inc?
Role: C SDET
Location: Hercules, CA (on-site)
3-5 Months Contract to Hire
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 SDET 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.
