Sr. R&D Program Manager

Abbott•Alameda, CA

23h•$148,700 - $297,300•Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: The Opportunity: The Sr. R&D Program Manager (Digital Health R&D) will be required to be On-site at our Alameda, California location, co-located with core delivery teams and leadership. The Sr Program Manager is an expert in project management for medical devices, with deep experience in regulated digital application delivery and design controls. They excel in day-to-day execution, anticipate risk early and ensure predictable, compliant outcomes. Working in partnership with the Technical Director, they strengthen operating cadence, discipline and cross-functional coordination while advancing a modern, data-driven operating model. What you’ll do: Day-to-Day Program Execution will focus on the following:

Requirements

10+ years in program/project management, including 5+ years in regulated digital health or software.
Bachelor’s degree in engineering or science equivalent.
Ability to travel 10% of the time, including internationally.

Nice To Haves

Ability to work in a matrixed and geographically diverse business environment with direct experience delivering global or multi-market releases with regional variability and change control.
Strong leadership and communication skills across multiple levels of the organization.
3+ years of experience directly managing technical staff.
Program/Project Management certifications.

Responsibilities

Guide teams through regulated product lifecycles, including design and development or change plans, release management and post-market support.
Own the delivery of a digital product or suite of product development initiatives by creating integrated plans, cross-functional schedules and dependencies.
Coordinate the resolution of technical challenges and translate tradeoffs to business teams in clear business terms.
Facilitate operating cadence (cross-functional meetings, design reviews), safeguard documentation and compliance (robust design control traceability and audit-ready design history files), enforce stage-gate criteria and continuous risk reduction.
Coach and mentor junior staff on SaMD regulations and development strategies.
Partner with engineering, quality, regulatory, privacy, security and clinical teams to assess risks related to updates, design changes, platform changes or integrations ensuring that appropriate mitigations are defined and implemented.
Coordinate and advise across digital application efforts for a globally diverse, multi-product connected system.
Ensure compliance with all relevant standards and quality expectations for digital health and software as a medical device, including: Quality management system and software lifecycle requirements Product safety and reliability expectations Mobile App observability and analytics tools Labeling and instructions for use Design control obligations under both US and International regulations
Focus on operational process improvement and systems optimization.
Identify and prioritize bottlenecks, inefficiencies and avoidable sources of rework across the project lifecycle.
Map and visualize workflows, process steps, data flows, decision pathways and stakeholder responsibilities to create shared understanding and address failure points.
Design and champion best practice processes and solutions that build consistency, adoption and operational excellence.