Program Manager (Sustaining)
Core
Leading structured sustainment programs for a portfolio of medical devices (hardware, SaMD, connected platforms) to ensure safety, compliance, and commercial viability throughout the lifecycle.
Role type
Senior Program Manager (Sustaining)
Builds
Sustainment initiatives including minor enhancements, defect remediation, cybersecurity updates, and regulatory-driven changes for in-market medical devices.
Domain
Medical Devices / Health Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Program management, risk management, regulatory compliance (FDA/ISO), cross-functional partnership, KPI tracking, stakeholder alignment
Preferred skills
SaMD experience, connected medical devices, post-market surveillance, CAPA management
Technologies
ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR Part 820, QMSR
Responsibilities
Managing integrated schedules, dependencies, risks, and issues; driving roadmap clarity for sustainment initiatives; partnering with Quality, Regulatory, and Clinical teams; ensuring regulatory and quality compliance; implementing continuous improvement initiatives.
Seniority
Senior, hands-on IC
