Senior Medical Device Software Engineer
4 days ago
Transforming Patient Care through Cutting-Edge Technology
X4 Life Sciences is a leading software medical device organization dedicated to revolutionizing patient care through innovative technology. As a pioneer in developing software solutions for medical devices, they are seeking a Medical Device Software Engineer to join their team and contribute to shaping the future of healthcare.
About the Role:
The Medical Device Software Engineer will be responsible for designing, developing, and testing software for medical devices in a regulated environment. This role requires a strong understanding of both software development and the medical device industry, with a focus on ensuring compliance with safety and performance standards.
Key Responsibilities:
- Design and develop 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.
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