R&D Program Manager (Enterprise Software)

The Program Manager is responsible for planning, executing, managing risk, managing critical paths and commercializing Enterprise Software projects according to strict deadlines and within budget. This includes engaging resources and coordinating the efforts of team members and third-party organizations to deliver projects according to plan. Accountable to create project team governance to engage in cross functional accountability of costs, schedules, scope, resources and track risks of programs and multiple integrated projects. Preference to candidates located in Massachusetts and Northeast region.

As a Program Manager the candidate will:

• Lead complex software development programs for medical device products in regulated environments, ensuring compliance with FDA, ISO 13485, IEC 62304, cybersecurity, and Quality Management System (QMS) requirements throughout the software development lifecycle.

• Manage programs involving both on-premises and cloud-based software platforms, coordinating architecture, infrastructure, validation, deployment, and release activities across cross-functional teams.

• Analyze program risks, assess business impact, develop mitigation strategies, manage critical paths, and lead programs from concept through commercialization.

• Create and execute project plans, adjusting scope, schedules, and resources as necessary to meet evolving business and technical requirements.

• Manage day-to-day program operations while ensuring compliance with Stage-Gate processes, quality systems, and standard operating procedures (SOPs). Escalate issues and risks appropriately.

• Partner closely with Software Engineering, Quality, Regulatory Affairs, Cybersecurity, Product Management, Clinical, and Operations teams to ensure successful delivery of enterprise software solutions supporting medical devices.

• Drive continuous improvement initiatives using Lean, Six Sigma, and other operational excellence methodologies to improve quality, efficiency, predictability, and delivery performance.

• Establish and monitor program metrics, KPIs, and dashboards to proactively identify risks, improve execution, and support data-driven decision-making.

• Coordinate software verification, validation, traceability, documentation, and release readiness activities for regulated medical device software products.

• Ensure deployment, implementation, and commercialization plans to address both customer-hosted (on-premises) and cloud-hosted environments while maintaining security, compliance, and quality requirements.

• Lead process standardization initiatives across software development teams, identify opportunities to streamline workflows, reduce cycle times, and improve product quality.

• Leverage project and portfolio management tools to develop, maintain, and communicate program schedules, milestones, dependencies, and status.

• Establish appropriate governance structures to ensure alignment, accountability, and clear decision-making across stakeholders.

• Maintain accountability for Design History File (DHF) deliverables, regulatory requirements, and compliance with applicable QMS procedures.

• Capture lessons learned and drive adoption of best practices across programs and project teams.

QUALIFICATIONS:

• Bachelor's degree required; B.S. in Engineering, Computer Science, or a related technical discipline preferred.

• 7+ years of Program or Project Management experience leading complex software development programs within the medical device, digital health, or other regulated healthcare technology industries.

• Proven experience managing enterprise software development programs supporting regulated medical device products; Class II and/or Class III device experience preferred.

• Experience leading programs involving both cloud-based (AWS, Azure, or GCP) and on-premises software deployments, releases, and lifecycle management.

• Strong understanding of Software Development Lifecycle (SDLC), Agile methodologies, DevOps practices, software verification and validation, and cybersecurity requirements in regulated environments.

• Working knowledge of FDA Quality System Regulations, IEC 62304, ISO 13485, ISO 14971, and other applicable medical device software standards preferred.

• SaaS and connected medical device platform knowledge preferred.

• Lean Six Sigma certification (Green Belt or Black Belt) or demonstrated experience leading process improvement and operational excellence initiatives preferred.

• Proven ability to lead and influence cross-functional teams including Software Engineering, Quality Assurance, Regulatory Affairs, Product Management, Clinical, and Operations stakeholders.

• Excellent executive-level communication, presentation, and stakeholder management skills, with experience communicating program status, risks, and mitigation plans to senior leadership.