Senior Project Manager / Delivery Manager

Spyrosoft Healthcare & Life Sciences Business Unit delivering complex software development projects for medical device manufacturers.

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, beyond agile delivery or software implementation.
• Proven participation in projects that successfully progressed through regulatory submission / conformity assessment resulting in product market release in the European Union under MDR / CE marking and/or 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 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 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 development practices as well as regulated / plan-driven development models with the ability to adapt delivery models to project and regulatory needs.
• 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 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-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.

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 software development activities comply with the agreed medical device software lifecycle and ISO 13485 Quality Management System;
• coordinating software development, QA/V&V, Quality & Regulatory, and other disciplines required for compliant medical device product delivery;
• 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 project documentation for regulatory submissions, conformity assessment, and audits;
• working closely with clients including senior technical, product, quality, and regulatory stakeholders;
• leading distributed, cross-functional engineering teams;
• identifying delivery and regulatory risks early and driving mitigation actions;
• managing changes to requirements and scope in a controlled environment;
• supporting estimations, project planning, commercial discussions, and preparation of Statements of Work;
• continuously improving delivery processes and ways of working;
• using modern AI tools to enhance project management, analysis, documentation, communication, and operational efficiency while maintaining confidentiality, quality, and human oversight.

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