Spyrosoft

Senior Project Manager / Delivery Manager – Medical Software

120 - 190 PLN/ godz./ godz.

SeniorOn-site·WrocławFull-time

#431873·Dodano miesiąc temu·13

Źródło: Spyrosoft

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Tech Stack / Keywords

Software DevelopmentEmbeddedCloudAIAgile CybersecuritySoftware Architecture

Firma i stanowisko

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

Wymagania

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

Obowiązki

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

Spyrosoft

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