Senior Project Manager / Delivery Manager – Medical Software

Spyrosoft is hiring an experienced Senior Project Manager / Delivery Manager to join their Healthcare & Life Sciences Business Unit and lead complex software development projects for medical device manufacturers.

• 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 at least one Software Safety Class C project
• Experience with the full medical software development lifecycle, including agile delivery and software implementation
• Participation in at least one project progressing through regulatory submission/conformity assessment resulting in product market release in the EU under MDR/CE marking and/or US 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 relation to software development and software risk controls
• Experience managing software lifecycle documentation, requirements, traceability, verification, validation evidence, and release readiness in regulated environments
• Strong project and delivery management skills 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 and regulated/plan-driven development models with ability to adapt delivery models
• Strong practical use of AI-assisted tools in professional work including 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 confidential and regulated contexts
• 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 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 various 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

• Lead end-to-end delivery of complex medical software development projects
• Manage project scope, schedule, budget, delivery risks, dependencies, and team capacity
• Ensure software development activities comply with the agreed medical device software lifecycle and ISO 13485 Quality Management System
• Coordinate software development, QA/V&V, Quality & Regulatory, and other disciplines to deliver compliant medical device products
• Ensure appropriate planning, traceability, risk management, verification, validation, and completeness of software lifecycle documentation
• Manage projects involving IEC 62304 Software Safety Class A-C software
• Support preparation and readiness of project documentation for regulatory submissions, conformity assessments, 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 changes to requirements and scope in a controlled environment
• Support estimations, project planning, commercial discussions, and Statements of Work preparation
• Continuously improve delivery processes and ways of working
• Use modern AI-assisted tools to enhance project management, analysis, documentation, communication, and operational efficiency while maintaining confidentiality, quality, and human oversight