Design Control Program Manager
Core
Leads planning, coordination, and execution of cross-functional programs subject to Design Controls for medical device development.
Role type
Senior Program Manager (Design Controls)
Builds
Medical device products (software, hardware, integrated product) for dialysis care
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features
Required skills
Program management, Design Controls expertise, Cross-functional coordination, Risk management, Integrated project planning, Stakeholder facilitation, Change management
Preferred skills
PMP/Agile/Scrum certification, FDA-regulated environment experience, Verification and validation knowledge, Portfolio planning
Technologies
Smartsheet, Jira, Azure DevOps, Microsoft Project, Excel, PowerPoint, Word, Power BI
Responsibilities
Develop and maintain integrated program plans and schedules; Facilitate governance forums and phase-gate reviews; Coordinate work across Engineering, Quality, Regulatory, and Operations teams; Maintain RAID logs and risk registers; Prepare executive dashboards and leadership presentations; Manage design changes and remediation programs
Seniority
Senior, hands-on IC