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Job Description
About This Role
The Senior Program Manager is a senior leadership role responsible for driving the successful execution of complex, cross-functional medical device development programs. Serving as a Core Team Leader, this individual is accountable for end-to-end program delivery, ensuring projects meet scope, schedule, budget, quality, and regulatory requirements.
This role combines program execution, technical leadership, client engagement, and business development support, guiding programs across the full product lifecycle—from concept through commercialization—while aligning internal teams and client expectations.
What You’ll Do
Lead cross-functional medical device development programs as Core Team Leader
Establish team structure, roles, accountability, and governance alignment
Drive end-to-end program execution including scope, schedule, and budget management
Develop and maintain program plans, milestones, and deliverables
Monitor project performance using KPIs (schedule, budget, risk, deliverables)
Identify and mitigate business and technical risks proactively to ensure successful outcomes
Ensure compliance with design control processes and regulatory requirements
Act as primary point of contact for clients; lead program communications and reviews
Align program delivery with client goals, regulatory strategies, and commercialization timelines
Facilitate collaboration across engineering, regulatory, quality, clinical, and operations teams
Provide program updates and escalation reporting to PMO and executive stakeholders
Ensure adherence to PMO governance frameworks and best practices
Support continuous improvement and lessons learned initiatives
Support business development with project extensions and change orders
Travel as needed to support program and client needs
Qualifications
Required:
Bachelor’s degree in Engineering, Biomedical Engineering, or a related technical field
10+ years of experience in medical device development or program management
Demonstrated experience leading cross-functional product development programs
Strong knowledge of medical device design controls and full development lifecycle
Experience operating in FDA-regulated and ISO-certified environments
Expertise in program management methodologies (scope, schedule, cost, risk, stakeholders)
Strong financial acumen including budgeting, forecasting, and resource planning
Excellent communication, stakeholder management, and leadership skills
Ability to manage multiple priorities with minimal supervision
Experience with program management tools (e.g., MS Project, Smartsheet, Jira)
Willingness to travel as required
Hybrid work environment based in Providence, RI
Preferred:
Master’s degree in Engineering or related discipline
PMP certification or equivalent
Experience in consulting or external product development environments
Understanding of regulatory pathways (e.g., 510(k), PMA, IDE, CE Mark)
Experience interpreting RFPs and developing executable program strategies
