Design Control Program Manager

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 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.

Support resource planning, roadmap development, scenario analysis, portfolio prioritization, and leadership decision-making.

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.

Required Qualifications

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

Minimum of 5 years of project or program management experience, including at least 3 years leading projects subject to Design Controls.

Demonstrated experience managing multiple concurrent product development, design change, remediation, or cross-functional projects from planning through execution and implementation.

Experience developing and maintaining integrated schedules and managing cross-functional dependencies, risks, issues, decisions, milestones, and recovery plans.

Experience applying Agile, Scrum, hybrid, stage-gate, or traditional project management methodologies based on project needs.

Experience using Smartsheet, Jira, Azure DevOps, Microsoft Project, Excel, PowerPoint, Word, or comparable project and portfolio management tools.

Strong written, verbal, and interpersonal communication skills, including the ability to present complex programs clearly to leadership, customers, and cross-functional stakeholders.

Strong leadership and influencing skills, with the ability to engage, motivate, and align cross-functional teams across multiple business functions and organizational levels.

Ability to anticipate challenges, balance competing priorities, navigate organizational complexity, and make timely decisions with incomplete information and under pressure.

Advanced English proficiency in written and spoken communication; strong organization, facilitation, change management, and customer-focused problem-solving skills.

Desired Qualifications

PMP, Agile, Scrum, or equivalent project or program management certification.

Experience in medical device, healthcare technology, or other FDA-regulated or highly regulated product development environments.

Familiarity with verification and validation, risk management, design transfer, manufacturing implementation, product release, sustaining engineering, or post-market activities.

Experience supporting remediation programs, CAPA-related initiatives, audit readiness, inspection response, or quality system improvement efforts.

Working knowledge of quality management systems, design change controls, and applicable software, hardware, or integrated product lifecycle requirements.

Advanced experience with Power BI, PPM platforms, portfolio dashboards, executive reporting, or portfolio-level resource and scenario planning.