Responsible for leading software projects focused around general purpose computing platforms and the cloud. Experienced in developing software to standards such as IEC 62304 and IEC 82304-1 including extensive knowledge in IEC 60601-1 (including usability and alarm systems collateral standards), ISO 14971, AAMI TIR57, ISO 13485 and IEC 62366-1.Responsible for managing the full life cycle for software development from planning and requirements to archiecture, design and implementation through to verification, validation and release.Strong focus on regulatory requirements and compliance particularly with FDA and EU MDR. Typically involved in writing and preparation of technical content within 510(k) submissions.