Spyrosoft

Senior Project Manager / Delivery Manager – Medical Software

120 - 190 PLN/ godz./ godz.B2BB2B (netto)

SeniorOn-site·WrocławFull-time·B2B

#431889·Dodano miesiąc temu·6

Źródło: nofluffjobs.com

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Tech Stack / Keywords

Project managementIECCISOrisk managementForecastingAIQuality assuranceCybersecurity

Firma i stanowisko

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.

Wymagania

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

Obowiązki

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

Spyrosoft

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