Principal SaMD Technical Program Manager

The Principal SaMD Technical Program Manager plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC 62304. They are responsible for creating and managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering practices. This approach empowers teams to innovate rapidly while maintaining audit-ready outputs and supporting the full product lifecycle, including post-market surveillance and ongoing compliance maintenance. 

Collaboration and leadership are central to this role. The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs, clinical, and quality assurance teams, facilitating strategic decision-making and resolving cross-functional dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable milestones.  They are responsible for tracking and communicating key metrics—such as risk information, documentation completeness, and team velocity—to both technical and business stakeholders. By engaging with executive leadership and managing demand from diverse sources, they ensure that product needs are clearly understood, prioritized, and delivered in alignment with organizational goals. 

As a catalyst for continual improvement, the Principal SaMD TPM researches, recommends, and implements new practices and automation opportunities to accelerate delivery and align activities with key business objectives and product initiatives. The role requires hands-on expertise in agile software development, process facilitation (Scrum, Kanban), and adaptive program management. Through a combination of technical acumen, process optimization, and collaborative leadership, they drive the organization’s mission to deliver safe, effective, and innovative medical software solutions.  

Responsibilities:  

• Lead SaMD Development Projects: Drive the functional planning, execution, and delivery of SaMD projects, ensuring effective delivery and alignment with relevant regulatory standards and organization SOPs. 

• Project Management: Apply best-practice project management methodologies to ensure adherence to project timelines, requirements, and goals.  Create and maintain dashboards, project plans, schedules, charters, and risk registers to monitor progress and performance, resolve operational issues, and minimize any p