Technical Program Manager
Core
Lead software releases and medical device product development from planning through commercial release and lifecycle management for regulated products.
Role type
Senior Technical Program Manager (Medical Devices)
Builds
Software-enabled medical device products and integrated release plans
Domain
Medical Devices / Regulated Software
Required skills
Release planning and execution, Regulatory compliance (21 CFR Part 820, ISO 13485), Risk management, Cross-functional stakeholder alignment, Agile delivery, Design controls, Quality system procedures, Resource management, Data-driven decision making
Preferred skills
FDA 510(k) submission experience, Advanced degree (Master's), PMP/PgMP/PMI-ACP certification
Technologies
Jira, Confluence, Microsoft Project, Miro, Dashboards
Responsibilities
Own integrated release plans and calendars from scope definition through deployment, Guide software-enabled medical device products from concept through regulatory clearance and launch, Confirm release readiness and compliance with design controls and quality procedures, Align Engineering, Quality, Regulatory, and external partners on scope and timing, Manage risks, dependencies, and defects across concurrent initiatives, Apply Agile and Lean practices to improve delivery in regulated environments
Seniority
Senior, hands-on IC