Senior Design Control Program Lead

Outset Medical, Inc.; Tijuana; Híbrido; MXN 1.891.000 - 2.751.000; Jornada completa

Descripción de la vacante

Outset Medical, Inc. seeks a Design Control Program Manager to lead cross-functional programs subject to Design Controls across software, hardware, and integrated products.

You will partner with Engineering, Quality, Regulatory Affairs, and Operations to drive execution readiness, manage risks, and provide clear program visibility in a regulated environment. The role develops integrated project plans, facilitates governance, tracks milestones, and ensures alignment with priorities and recovery

Formación

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Technical Management, or a related field; master’s degree preferred.

Responsabilidades

• 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 communicate program status, executive dashboards, review materials, leadership presentations, risks, dependencies, resource constraints, key decisions, and recovery plans.
• Maintain product roadmaps, design change plans, release plans, implementation plans, and reporting dashboards using Smartsheet, Jira, Microsoft Project, or comparable tools.
• Partner with Quality and Regulatory teams to understand requirements related to design and development, design changes, verification, validation, remediation, manufacturing implementation, and product release activities.
• Promote accountability, collaboration, and cross-functional alignment through effective facilitation, stakeholder engagement, and clear communication.
• Manage change within assigned programs by helping teams adapt to shifting priorities, changing conditions, and unexpected obstacles while maintaining focus on program outcomes.

Conocimientos

Leadership

Strong communication

Planning & scheduling

Risk management

Cross-functional collaboration

Agile/Scrum

Problem solving

Presentation skills

English proficiency

Facilitation

Educación

Bachelor’s degree in Engineering/CS/Life Sciences/Technical Management

Master’s degree preferred

Herramientas

Smartsheet

Jira

Azure DevOps

Microsoft Project

Excel

Power BI

Descripción del empleo

Outset Medical, Inc. seeks a Design Control Program Manager to lead cross-functional programs subject to Design Controls across software, hardware, and integrated products.

You will partner with Engineering, Quality, Regulatory Affairs, and Operations to drive execution readiness, manage risks, and provide clear program visibility in a regulated environment. The role develops integrated project plans, facilitates governance, tracks milestones, and ensures alignment with priorities and recovery