Senior Project Manager / Delivery Manager – Medical Software

The position is within the Healthcare & Life Sciences Business Unit at SpyroSoft Solutions S.A., focusing on software development projects for medical device manufacturers.

• Minimum 5 years hands-on Project Management/Delivery Management in medical device software development projects
• Experience managing software development per IEC 62304, including at least one Software Safety Class C project
• Full lifecycle knowledge of medical software development beyond agile delivery
• Participation in projects that achieved regulatory submission/conformity assessment and market release in the EU (MDR/CE marking) and/or US (FDA pathway)
• Practical understanding of medical device QMS and ISO 13485
• Practical understanding of medical device risk management per ISO 14971 related to software
• Experience managing software lifecycle documentation, requirements, traceability, verification, validation, and release readiness
• Strong project and delivery management skills covering scope, budget, planning, risks, and change management
• Experience working directly with customers and senior stakeholders
• Experience leading distributed and cross-functional teams
• Good understanding of Agile and regulated/plan-driven development models
• Proficient use of AI-assisted tools for project management and able to critically evaluate AI-generated outputs in regulated environments
• 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 submission activities
• Knowledge of additional medical device standards such as IEC 62366-1, IEC 81001-5-1, or cybersecurity requirements
• Experience with SaMD, connected medical devices, medical imaging, diagnostic software, or other safety-critical healthcare systems
• Experience delivering projects under Time & Material and Fixed Price commercial models
• Experience in presales, project estimation, proposal preparation, and client workshops
• Technical or engineering background enabling effective cooperation with software architects and engineering teams

• Manage end-to-end delivery of complex medical software development projects
• Oversee project scope, schedule, budget, delivery risks, dependencies, and team capacity
• Ensure software development complies with medical device software lifecycle and ISO 13485 Quality Management System
• Coordinate cross-discipline teams including software development, QA/V&V, Quality & Regulatory
• Ensure proper planning, traceability, risk management, verification, validation, and documentation completeness
• Manage projects compliant with IEC 62304 Software Safety Class A-C
• Support preparation and readiness of regulatory submission documentation
• Engage closely with clients and senior stakeholders across technical, product, quality, and regulatory areas
• Lead distributed, cross-functional engineering teams
• Identify and mitigate delivery and regulatory risks early
• Manage changes to requirements and scope in a controlled environment
• Support estimation, project planning, commercial discussions, and preparation of Statements of Work
• Continuously improve delivery processes and ways of working
• Employ modern AI tools in project management, analysis, documentation, communication, and workflow automation while ensuring confidentiality and quality