Program Manager, NPI

📋 Description

• Lead complex cross-functional new product introduction programs for connected medical devices from
• Partner with hardware, firmware, mobile/app, regulatory, quality, clinical, manufacturing, and
• Drive program-level risk management in accordance with ISO 14971, proactively identifying
• Own and maintain integrated program schedules, design history file milestones, phase-gate
• Serve as a force multiplier for functional leaders by identifying obstacles, coordinating issue
• Coordinate device connectivity initiatives, including Bluetooth/BLE, companion applications, cloud

🎯 Requirements

• 12+ years of professional experience, including at least 5 years in program or project management
• Bachelor’s degree or higher preferred, or equivalent combination of education and relevant
• Demonstrated experience leading new product introduction programs for connected or
• Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, IEC 62304, and ISO
• Experience partnering closely with Regulatory and Quality teams to execute design controls and
• Proven ability to coordinate hardware, firmware, mobile/application, and connected software

🎁 Benefits

• Remote work opportunity within the United States.
• Opportunity to lead innovative connected medical device programs with meaningful potential impact
• Mission-driven and collaborative work environment focused on innovation and improving patient and
• Cross-functional exposure to hardware, software, firmware, clinical, regulatory, quality, and
• Opportunity to influence products throughout the full lifecycle, from early concept through
• Professional growth opportunities through involvement in complex, multidisciplinary programs.