3 of 3 ISO 13485 Jobs in Cambridge

systems Lead firmware architecture, requirements definition, and design from early concept through product release Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971.Act as the firmware compliance leader, guiding the team … experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages Demonstrated experience working within an ISO 13485certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software ...

similar tools. Working within regulated, compliance-driven environments. Highly Desirable Healthcare software experience. Medical device software experience. Software as a Medical Device (SaMD). ISO 13485 exposure. IEC 62304 exposure. Validation and verification (V&V) activities. Audit-ready documentation and traceability management. ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...