Software Engineer – Medical Devices
Software Engineer – Medical Devices (2+ Years Experience) Location: Remote (Texas) Experience: 2+ Years Employment Type: W2 contract Job Description: We are seeking a Software Engineer with 2+ years of experience in the Medical Devices or Healthcare domain. The ideal candidate will be involved in software development, testing, and maintenance of regulated medical device products while ensuring compliance with FDA and industry standards. Candidates with experience in embedded systems, firmware, healthcare applications, or Software as a Medical Device (SaMD) environments are highly preferred. Responsibilities:
- Design, develop, test, and maintain software applications for medical device products
- Participate in full Software Development Life Cycle (SDLC)
- Develop and execute unit testing, integration testing, and verification activities
- Work with cross-functional teams including QA, Regulatory, Systems, and Hardware teams
- Maintain documentation in compliance with FDA and regulatory standards
- Support software risk analysis, troubleshooting, and defect resolution
- Ensure compliance with IEC 62304, ISO 13485, and design control processes
Required Skills:
- 2+ years of software engineering experience
- Experience working with Medical Device or Healthcare clients/projects
- Strong programming skills in C++, C, Python, Java, or Embedded Systems
- Knowledge of SDLC, software validation, and verification processes
- Familiarity with FDA-regulated environments
- Understanding of IEC 62304 and ISO 13485 standards is preferred
- Strong problem-solving and communication skills
Preferred Skills:
- Embedded/Firmware development
- Linux or RTOS environments
- Software as a Medical Device (SaMD)
- Medical Imaging or Healthcare Applications
- Automation testing or V&V experience
- Agile/Scrum methodology exposure
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