OverviewThe Senior Program Manager leads complex, cross-functional medical device development programs from concept and feasibility through verification, validation, regulatory activities, and pre-clinical support. This role is accountable for end-to-end program execution across the product lifecycle and partners closely with R&D, Systems Engineering, Quality, Regulatory Affairs, Clinical, Operations, and suppliers to ensure successful delivery of products while maintaining compliance with FDA, ISO, and quality system requirements.
The Senior Program Manager is responsible for driving program execution across multiple workstreams while supporting technical integration, risk management, product development deliverables, and stakeholder alignment to meet business and customer needs.
Primary Responsibilities- Own integrated program plans and drive execution across multiple cross-functional workstreams.
- Manage scope, schedule, budget, resources, risks, and dependencies while ensuring clear communication to stakeholders.
- Lead program governance activities, including core team meetings, design reviews, milestone tracking, action item management, and executive reporting.
- Coordinate system-level integration activities, verification and validation planning, and requirements traceability.
- Lead cross-functional planning and execution for hardware, software, firmware, and system-level product development activities.
- Partner with Quality and Regulatory teams to ensure compliance with design controls, product development standards, risk management requirements, and quality system expectations.
- Support Design History File (DHF) deliverables, documentation traceability, and audit readiness.
- Drive program-level risk management by identifying, assessing, and mitigating technical, schedule, supplier, quality, and regulatory risks.
- Manage change control activities and ensure impacts to scope, schedule, budget, and technical requirements are properly evaluated and communicated.
- Manage supplier deliverables, schedules, quality expectations, and overall supplier performance to support program objectives.
- Provide executive-level visibility into program health, milestone progress, critical path activities, resource constraints, risks, and key decisions.
- Contribute to the continuous improvement of product development and program management processes, tools, and governance practices.
Job Requirements- Lead low- and high-complexity cross-functional projects and programs, including supplier engagements and business initiatives.
- Operate independently while supporting the needs of project teams, functional leaders, and senior management.
- Develop and maintain integrated program schedules, including dependency management, critical path analysis, and trade-off decision making.
- Drive program and project-level decisions to achieve key milestones and business objectives.
- Support audits and ensure program documentation is complete, consistent, and traceable.
- Manage supplier-driven schedules and risks while translating technical complexity into actionable plans.
- Prioritize requirements and program scope to meet business and customer needs.
- Develop and maintain standard project management deliverables, including schedules, budgets, status reports, meeting documentation, risk assessments, and action item tracking.
Qualifications- Bachelor's degree in a technical field, preferably Engineering (Systems, Software, Electrical, Biomedical Engineering, or related discipline); advanced degree (MS, MBA, or similar) preferred.
- PMP certification preferred.
- 10+ years of program or project management experience in the medical device industry or another regulated environment.
- Knowledge and experience with the full product development lifecycle.
- Proven experience leading complex hardware, software, firmware, and systems development programs.
- Strong understanding of FDA regulations, quality systems, design controls, risk management, and product development lifecycles.
- Successful track record working within regulated product development environments and quality systems.
- Demonstrated ability to lead cross-functional teams, manage suppliers, and communicate effectively with executive stakeholders.
- Strong systems-level thinking across functional groups preferred.
- Systems-level program management experience preferred.
