Position Overview
The Design Control Program Manager leads the planning, coordination, and execution of cross-functional programs subject to Design Controls, including software, hardware, integrated product, remediation, design change, and other strategic initiatives. This role partners with Engineering, Quality, Regulatory Affairs, Clinical, Operations, Manufacturing, Supply Chain, external partners, and leadership stakeholders to drive execution readiness, manage risks and dependencies, and provide clear program and portfolio visibility in a regulated environment.
The role develops and maintains integrated project plans, facilitates governance and decision-making forums, tracks actions and milestones, supports resource and roadmap planning, and ensures teams remain aligned on priorities, commitments, and recovery plans.

Essential Job Functions and Responsibilities
• Develop, maintain, and manage integrated program plans, schedules, milestones, critical paths, and dependencies across software, hardware, integrated product, remediation, design change, and ad hoc projects.




• Facilitate planning sessions and establish realistic execution timelines based on scope, resource availability, technical dependencies, and quality or regulatory requirements.
• Lead program team meetings, governance forums, phase-gate reviews, design reviews, and planning reviews to drive decisions, alignment, and timely follow-up.
• Coordinate work across Software Engineering, Hardware Engineering, Systems Engineering, Quality Assurance, Regulatory Affairs, Operations, Clinical, Manufacturing, Supply Chain, and external partners.
• Maintain RAID logs, risk registers, action trackers, and dependency logs; drive risk identification, prioritization, mitigation, escalation, resolution, and recovery planning.
• Track cross-functional commitments, milestones, overdue actions, verification activities, defect assessments, testing impacts, remediation work, and implementation readiness.
• Prepare and c

📌 Design Control Program Manager (México)
🏢 Outset Medical
📍 México