Lead 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 decisio...