Technical Program Manager
Core
Coordinates the development of a medical device across hardware, optics, software, imaging, systems engineering, quality, regulatory, clinical and manufacturing workstreams.
Role type
Technical Program Manager (Medical Device Development)
Builds
Medical devices (hardware/software systems)
Domain
Medical Technology / Regulatory Compliance
Required skills
Integrated program planning, Engineering operations, Bills of materials management, Configuration control, Inventory tracking, Purchasing coordination, Risk management, Cross-functional coordination, Regulatory documentation, Supplier management
Preferred skills
Class II medical device development, FDA regulatory submission, Design controls, ISO 13485/14971/62304/60601 standards, Surgical imaging/robotics experience, PLM/QMS tools proficiency
Technologies
Jira, Confluence, Smartsheet, Asana, Arena, OpenBOM
Responsibilities
Maintain integrated development plan and milestones, Lead milestone reviews and drive blockers to closure, Coordinate prototype builds and clinical activities, Maintain bills of materials and configuration records, Track inventory and manage supplier orders, Support design controls and regulatory documentation workflows, Provide leadership updates on progress and risks
Seniority
Mid-Senior, hands-on IC