Your role: Leading structured sustainment programs aligned to organizational goals, ensuring delivery within defined scope, schedule, and budget constraints. Providing end-to-end governance across planning, execution, and delivery with limited supervision and strong ownership. Managing program execution rigor, including integrated schedules, dependencies, risks, and issue tracking, clear escalation pathways and decision-making forums. Providing transparent reporting to leadership on scope, timelines, quality, and compliance. Owning the sustainment program management for a portfolio of medical devices, including hardware, Software as a Medical Device (SaMD), and connected digital platforms. Ensuring products in the field remain safe, effective, compliant, and commercially viable throughout the full lifecycle. Driving the roadmap clarity and execution for sustainment initiatives such as minor enhancements, defect remediation, cybersecurity updates, and regulatory-driven changes. Balancing speed, quality, and compliance to support revenue continuity and customer satisfaction. Implementing and managing detailed program plans covering timelines, resourcing, risk management, and cross-functional dependencies. Monitoring performance using KPIs such as schedule and cost variance, proactively identifying and mitigating risks to keep programs on track. Partnering cross-functionally with Quality, Regulatory, Clinical, and Post‑Market Surveillance teams to monitor field performance and manage risk. Applying structured risk assessment practices (e.g., ISO 14971) to proactively identify issues and ensure timely, compliant remediation. Ensuring regulatory and quality compliance across all sustainment activities, including adherence to FDA 21 CFR Part 820/QMSR, ISO 13485, IEC 62304, ISO 14971 and cybersecurity and data privacy requirements (as applicable). Driving continuous improvement initiatives to enhance efficiency of sustainment operations, reduce cycle time, and improve product reliability and customer experience. Enabling data-driven decision making by defining and tracking key KPIs.
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Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed