POSITION SUMMARY

Inspire Medical Systems is seeking an experienced and highly strategic Senior Program Manager to lead the cross-functional execution of next generation neurostimulator development programs through design verification & validation, FDA submission, regulatory approval, and commercial launch.

This role will serve as the central leader responsible for planning, coordinating, and driving the successful execution of one or more of the company's most critical product development initiatives. The Senior Program Manager will work across product development and the enterprise to create plans, ensure alignment, manage risks, and achieve key project milestones while optimizing resources and budgets across multiple concurrent projects.

The ideal candidate has extensive experience leading multiple, concurrent Class II or Class III medical device projects through design verification, design validation, regulatory submissions, and commercialization.

MAIN DUTIES/RESPONSIBILITIES

• Program Leadership
  • Lead new product design and integration work from design verification & validation through FDA approval and commercial launch.
  • Develop and maintain integrated project plans, schedules, critical path analyses, and resource forecasts.
  • Create and monitor program budgets in partnership with functional leaders, driving cost efficiencies and financial accountability.
  • Drive project governance, phase-gate reviews and project team decision making.
  • Partner with internal and external stakeholders to define and manage program scope and strategic priorities, ensuring cross-functional alignment around objectives, risks, timelines, and business outcomes.
  • Contribute to the growth and maturity of the PMO by standardizing program management best practices, tools, and templates.
  • Coach and mentor project team members and functional managers in program and risk management best practices.
  • Build and execute communication plans for project teams, key stakeholders, and executive leadership.

• Project Risk Management
  • Develop and maintain program risk management plans, risk logs, and escalation processes.
  • Identify, assess, and mitigate technical, clinical, regulatory and launch risks.
  • Lead cross-functional risk reviews and executive escalations.
  • Develop contingency plans for critical path activities.

• Product Development Execution
  • Coordinate execution of Design Verification activities.
  • Monitor completion of design inputs, outputs, verification protocols, test reports, and technical documentation to build the design history file.
  • Partner with engineering teams to ensure technical deliverables are completed on schedule.
  • Facilitate issue resolution across cross-functional teams.

• Regulatory & Quality Leadership
  • Coordinate preparation of FDA submission packages with Regulatory team.
  • Partner with Regulatory Affairs and Quality Assurance to ensure compliance with applicable standards and regulations such as:
    • FDA Design Controls
    • 21 CFR Part 820
    • ISO 13485
    • ISO 14971

• Launch Readiness
  • Coordinate launch planning activities across Marketing, Commercial, Clinical, and Customer Service.
  • Establish launch success metrics and readiness criteria.
  • Drive completion of all launch deliverables and executive launch approvals.
  • Monitor launch execution and post-market stabilization activities.

QUALIFICATIONS

Educational Requirements:

·         Bachelor's degree in Engineering, Science, Business, or related field.

Required Experience:

• 10+ years of relevant project or program management experience.
• 4+ years leading complex medical device development projects.
• Demonstrated success leading products from development through regulatory approval and commercial launch.
• Proven ability to lead multiple concurrent projects and cross-functional teams without direct authority.
• Experience with FDA submissions for Class II and/or Class III medical devices.
• Strong communication, stakeholder engagement, and strategic planning skills, including presenting to executive leadership.
• Proficiency with program management tools (e.g., Microsoft Project, Smartsheet, AI).
• Strong understanding of:
  • Design Controls
  • Product Development Lifecycle
  • Design Verification and Validation
  • FDA regulatory processes
  • Quality Systems

Preferred Experience:

• Implantable medical devices.
• Neurostimulation products.
• Electromechanical medical systems.
• A variety of program management methodologies, including Agile and Stage-Gate development models.
• PMO and portfolio governance environments.
• Led at least one major medical device program from proof of concept through pilot production and market introduction.
• Experience using generative AI for common tasks like meeting minutes, dashboarding, reporting, communications
• Experience managing budgets, timelines, and risks under contractual commitments with external development partners.
• PMP, PgMP, or equivalent program management certification.
• Master’s degree in Engineering, Science, Business, or related field.

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