Senior Project Manager / Delivery Manager (Medical Software)

Quick Facts

• Role: Senior Project Manager / Delivery Manager for medical software delivery

Description

Lead end-to-end delivery of complex medical software development projects in a regulated medical device environment. Ensure delivery follows an agreed medical device software lifecycle and applicable Quality Management System requirements (ISO 13485), including risk management, verification and validation, and complete software lifecycle documentation. Coordinate cross-functional teams (software development, QA/V&V, Quality/Regulatory) to support compliant product release and market access across embedded, desktop, cloud, imaging, connected medical devices, or SaMD.

Responsibilities

• Manage project scope, schedule, budget, delivery risks, dependencies, and team capacity.

• Ensure appropriate planning, traceability, risk management, verification/validation, and completeness of required software lifecycle documentation.

• Manage projects involving IEC 62304 Software Safety Class A–C.

• Support readiness of project documentation for regulatory submissions, conformity assessment, and audits.

• Work closely with clients, including senior technical, product, quality, and regulatory stakeholders.

• Lead distributed, cross-functional engineering teams.

• Identify delivery and regulatory risks early and drive mitigation actions.

• Manage controlled changes to requirements and scope.

• Support estimations, project planning, commercial discussions, and Statements of Work.

• Continuously improve delivery processes and ways of working.

• Use modern AI tools to improve project management, analysis, documentation, communication, and operational efficiency while maintaining confidentiality, quality, and human oversight.

Requirements

• Minimum 5 years of hands-on Project Management / Delivery Management experience in software development for medical devices or medical device software.

• Proven experience managing software development according to IEC 62304, including at least one Software Safety Class C project.

• Experience with the full medical software development lifecycle.

• Participated in at least one project that progressed through regulatory submission/conformity assessment and resulted in product market release in the EU (MDR/CE marking) and/or the US (applicable FDA pathway).

• Practical understanding of medical device Quality Management Systems and ISO 13485.

• Practical understanding of medical device risk management per ISO 14971 and its relationship to software development and software risk controls.

• Experience managing software lifecycle documentation, requirements, traceability, verification and validation evidence, and release readiness.

• Strong project and delivery management capabilities (scope, budget, forecasting, planning, dependencies, risks, change management).

• Experience working directly with customers and senior stakeholders.

• Experience leading distributed and cross-functional engineering teams.

• Understanding of Agile and plan-driven development models; ability to adapt delivery approach to regulatory needs.

• Strong practical use of AI-assisted tools in everyday professional work (analysis, documentation, reporting, planning, risk analysis, meeting follow-up, workflow automation) and ability to critically evaluate AI outputs for confidential/regulatory environments.

• Excellent communication, negotiation, and stakeholder-management skills.

• English fluency (minimum C1).

Benefits

Not specified in the provided posting.