Senior Project Manager / Delivery Manager - Medical Software

O projekcie 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.

About Spyrosoft

Spyrosoft is an authentic, cutting-edge software engineering company, established in 2016. In 2021 and 2022, we were among the fastest growing technology companies in Europe, according to the Financial Times. We were founded by a group of tech experts with established backgrounds in software engineering, who created an ‘engineer-to-engineer’ workplace, powered by enthusiasm, fairness and authentic relationships. Having a unique offering, which bridge the gap between technology and business, we specialise in technology solutions for industry 4.0, automotive, geospatial, healthcare & life sciences, employee experience & education and financial services industries.

Zakres obowiązków

• end-to-end delivery of complex medical software development projects;
• managing project scope, schedule, budget, delivery risks, dependencies and team capacity;
• ensuring that software development activities are performed in accordance with the agreed medical device software lifecycle and applicable Quality Management System according to the ISO 13485;
• coordinating software development, QA/V&V, Quality & Regulatory and other disciplines required to deliver a compliant medical device product;
• 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 required 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 improve project management, analysis, documentation, communication and operational efficiency while maintaining appropriate confidentiality, quality and human oversight.

Wymagania 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.