The Program Manager - Software owns complex, technically challenging software programs (SaMD and SiMD), for new products and improvements to existing products, from initiation through maintenance. This role bridges technical engineering with business strategy to maximize product performance and patient safety. They lead cross-functional teams ensuring effective completion of the program. They act as the primary liaison between project teams and senior leadership providing transparent reporting on budgets, timelines, and milestones. At this level, they will bring wide-ranging experience and use professional concepts paired with company objectives to resolve complex issues in creative and effective ways. They build robust internal networks and lead in the development and training for best practices.
Essential Duties and Responsibilities:
Program Leadership: Lead cross-functional core teams (R&D;, Quality, Operations, Marketing, etc.) through the execution of the software development lifecycle (SDLC) for medical device products.
Build and manage the integrated schedule and balance resourcing against it providing updates through project scorecards. Manage initial scope definition and prevent scope creep. Author project charters where required. Hold owners accountable for functional QMS and business deliverables. Lead preparation and execution of stage-gate reviews. Resolve conflicts. Identify and manage interdependencies with other projects.
Stakeholder Communication: Serve as the primary liaison between project teams and leadership, providing transparent reporting. Act as point of escalation if needed.
Risk and Issue Management: Proactively identify, assess, and mitigate program-level risks and issues, developing contingency plans and initiating corrective actions when needed. Manage lessons learned.
Compliance: Ensure all software development processes adhere to international standards, including IEC 62304 (Software Lifecycle), ISO 13485 (Quality Management), and
📌 Program Manager, Software (Sevilla)
🏢 Hologic
📍 Sevilla
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