Lead overall program/project execution for the Edge AI & Connectivity Platform, driving timelines, budgets, compliance, and stakeholder alignment
Manage Agile sprint planning, backlog grooming, dependency mapping, and change request processes
Coordinate workstreams involving embedded firmware, edge computing, AI/ML pipelines, cloud services, and regulatory documentation
Serve as the single point of accountability for internal teams and client delivery leads
Ensure alignment with medical device regulations and standards, including: FDA 510(k), HIPAA and GDPR, IEC 62304, ISO 13485, ISO 14971
Track and mitigate risks, manage RAID logs, and ensure proactive escalation and resolution of delivery blockers
Monitor traceability from user needs to validation artifacts to ensure audit readiness and compliance documentation
Collaborate with domain SMEs, architects, QA leads, and business analysts to ensure functional and technical completeness
Conduct regular client-facing meetings, sprint demos, roadmap updates, and steering committee presentations
Maintain release cadence and ensure documentation for design controls, V&V, and change management

7+ years of experience in technical project/program management
5+ years leading delivery in regulated product development, ideally in MedTech, HealthTech, or Industrial IoT
Experience managing globally distributed engineering teams with Agile/Hybrid execution
Strong working knowledge of embedded systems, data engineering pipelines, AI/ML model lifecycle, and edge-to-cloud architectures
Proven ability to collaborate with regulatory teams and contribute to submission readiness (e.g., FDA 510(k), CE Marking)
Familiarity with Design History File (DHF), traceability matrices, and regulatory design controls
Experience supporting quality audits and contributing to documentation required by Notified Bodies or FDA reviewers
Exposure to medical cybersecurity frameworks and privacy risk assessments
Comfortable navigating architecture decisions related to: Edge devices (e.g., ARM Cortex, NVIDIA Jetson)
Strong experience with project management tools (JIRA, Confluence, MS Project, Miro)

IT Project Manager

Key skills