The SaMD Architect will be working with the product and software engineering team to ensure different customer solutions are designed, architected, documented and implemented according to medical device design and development requirements from regulatory bodies.
- Co-lead design, architecture, and development of SaMD
- Test life cycle management, meeting all regulatory, quality, data privacy, and cybersecurity standards.
- Integration testing, software FMEA, performance analysis, reliability analysis, and root cause analysis.
- Ensure traceability of software requirements into software architecture and design specifications
- Strong experience in SaMD classified as Class 2 and/or Class 3 medical device.
- Demonstrated applied expertise in FDA design control requirements (21 CFR 820.30)
- The expertise of ISO 13485, ISO 14971, Cybersecurity, IEC 62366, and IEC 62304
- Demonstrated Experience following Agile methodology