Senior Project Manager / Delivery Manager – Medical Software

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).

What we are looking for

We are looking for someone who can combine strong delivery ownership with an understanding of regulated medical software development.

The ideal expert is comfortable discussing project economics and delivery risks with management, software architecture and dependencies with engineering teams, and regulatory readiness, evidence and documentation with Quality and Regulatory stakeholders.

Most importantly, we are looking for someone who has already experienced what it takes to bring medical software from development through the regulated lifecycle to an actual market release — and can confidently lead others through that process.

Must have

• Minimum 5 years of hands-on Project Management / Delivery Management experience in software development projects for medical devices or medical device software.
• Proven experience managing software development according to IEC 62304, including direct experience with at least one Software Safety Class C project.
• Experience with the full medical software development lifecycle, not limited to agile delivery or software implementation.
• Proven participation in at least one project that successfully progressed through regulatory submission / conformity assessment and resulted in product market release in:
  • the European Union under MDR / CE marking, and/or
  • the United States through an applicable FDA pathway.
• Practical understanding of medical device Quality Management Systems and ISO 13485.
• Practical understanding of medical device risk management according to ISO 14971 and its relationship with software development and software risk controls.
• Experience managing software lifecycle documentation, requirements, traceability, verification and validation evidence and release readiness in a regulated environment.
• Strong project and delivery management capabilities covering scope, budget, forecasting, planning, dependencies, risks and change management.
• Experience working directly with customers and senior stakeholders.
• Experience leading distributed and cross-functional engineering teams.
• Good understanding of Agile development practices as well as regulated / plan-driven development models. Ability to adapt the delivery model to project and regulatory needs rather than applying one methodology mechanically.
• Strong practical use of AI-assisted tools in everyday professional work, including areas such as information analysis, documentation, reporting, project planning, risk analysis, meeting follow-up and workflow automation.
• Ability to critically evaluate AI-generated outputs and use AI appropriately in environments involving confidential and regulated information.
• Excellent communication, negotiation and stakeholder-management skills.
• Fluency in English, minimum C1 level.

Nice to have

• Experience with both EU MDR and FDA-regulated products.
• Experience interacting with Quality Assurance, Regulatory Affairs, auditors, Notified Bodies or FDA-related submission activities.
• Knowledge of additional medical device standards and guidance, such as IEC 62366-1, IEC 81001-5-1 or related cybersecurity requirements.
• Experience with SaMD, connected medical devices, medical imaging, diagnostic software or other safety-critical healthcare systems.
• Experience delivering projects under different commercial models, including Time & Material and Fixed Price.
• Experience in presales, project estimation, proposal preparation and client workshops.
• Technical or engineering background enabling effective cooperation with software architects and engineering teams.