About This RoleThe Principal 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 by leading project execution strategy development for RFPs and proposals
- Serve as Proposal Owner and technical advisor to clients for new and expanding business opportunities
- Travel as needed to support program and client needs
QualificationsRequired:- Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field
- 10+ years of experience in medical device development or program management
- 2+ years of experience supporting business development or client-facing activities
- 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
