Medical Device Software Engineer
X4 Life Sciences are partnered software medical device organization dedicated to transforming patient care through cutting-edge technology. They specialize in developing software solutions that power medical devices, improving patient outcomes and enhancing the overall healthcare experience. As they expand their product line, they are looking for a Medical Device Software Engineer to join their team and help shape the future of healthcare.
About the Role:
The Medical Device Software Engineer will develop and maintain software for medical devices in a regulated environment. You will ensure compliance with safety and performance standards while delivering robust software that integrates seamlessly with hardware components. A strong understanding of both software development and the medical device industry is essential.
Key Responsibilities:
- Design, develop, and test software for medical devices according to IEC 62304 and other relevant standards.
- Collaborate with hardware engineers, product managers, and regulatory specialists to deliver integrated solutions.
- Ensure compliance with FDA and ISO 13485 regulations.
- Conduct risk analysis and ensure software safety for medical applications.
- Participate in code reviews and testing to enhance software quality.
- Contribute to regulatory documentation and stay current with industry advancements.
Requirements:
- 5+ years of software engineering experience in the medical device industry.
- Proficiency in C/C++ and/or Python, with a focus on embedded systems.
- Familiarity with FDA, ISO 13485, IEC 62304 standards.
- Experience in real-time software development and hardware interfaces.
- Strong problem-solving skills and attention to detail in a regulated environment.
