Senior Technical Program Manager

Job Summary

Managing the release of FDA-approved software for medical devices, the full-time Senior Technical Program Manager will lead cross-functional coordination and ensure compliance with quality management systems while working remotely.

Key responsibilities

• Lead release program activities, defining scope, schedule, and milestones for software as a medical device (SaMD)
• Coordinate cross-functional release activities across various teams including Engineering, Software QA, and Regulatory
• Ensure compliance with quality management systems and applicable standards, driving documentation completion and audit readiness

Required qualifications

• Experience in program management, specifically within medical device software delivery
• Knowledge of medical device regulations and quality management systems (e.g., ISO 13485, IEC 62304)
• Proven ability to manage release processes and cross-team dependencies
• High School Diploma or equivalent required
• Experience in providing clear and timely status reporting to stakeholders