Senior Project Manager / Delivery Manager

We are looking for an experienced Senior Project Manager / Delivery Manager to join our Healthcare & Life Sciences Business Unit and lead complex software development projects for medical device manufacturers. This is not a generic software project management role. We are looking for someone who understands the realities of delivering software in a regulated medical device environment, from planning and software development, through risk management, verification and validation and regulatory documentation, to successful product release and market access.

Our projects may involve embedded, desktop, cloud, imaging, connected medical devices or Software as a Medical Device (SaMD). Scope of Services You will be accountable for: end-to-end delivery of complex medical software development projects; managing project scope, schedule, budget, delivery risks, dependencies and team capacity; ensuring that software development activities are performed in accordance with the agreed medical device software lifecycle and applicable Quality Management System according to the ISO 13485; coordinating software development, QA/V&V, Quality & Regulatory and other disciplines required to deliver a compliant medical device product; ensuring appropriate planning, traceability, risk management, verification and validation and completeness of required software lifecycle documentation; managing projects involving IEC 62304 Software Safety Class A-C software; supporting preparation and readiness of proj