Staff Technical Program Manager

8+ years of technical program manager experience, or an equal combination of relevant experience. BS in Engineering preferred or other relevant field with prior experience. Certified scrum master with demonstrated experience facilitating agile processes. Excellent verbal and written communication skills. Demonstrated work history maintaining product documentation & versioning within a Quality Management System. Ability to engage technical and non-technical audiences. Proven ability to build relationships, collaborate, and influence internal teams and partners. Strong analytical and problem solving skills. Capability to succeed in a fast-paced environment with shifting priorities and manage competing priorities. Previous experience working daily with data scientists, engineers, product managers, regulatory and quality teams, and clinicians in a digital health environment. Previous experience working in a start-up environment with a highly collaborative culture. Experience working in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations.

Lead the development team from planning through verification and validation. Communicate and coordinate activities across product, engineering, AI, regulatory, quality, and external partnership teams. Develop and maintain SOPs, work instructions, and other process documentation. Lead risk analysis activities in accordance with ISO 14971 and IEC 62304. Trace requirements to product architecture, system design, and verification/validation test cases. Coordinate with AI scientists, engineers, and product managers for regulatory submission documentation. Run agile ceremonies and orchestrate sprint and project milestones. Ensure engineers have necessary information, requirements, and acceptance criteria for feature implementation. Coordinate with engineering managers and product managers on release planning, timelines, and documentation. Provide executive-level reporting on program status, risks, and critical path items. Lead bug triage and prioritization.