Sr. Program Manager

The role

Lead the cross-functional execution of next generation neurostimulator development programs. Work from design verification and validation through FDA submission, regulatory approval and commercial launch.

What you will do

• Lead new product design and integration work from design verification and 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 with functional leaders
• Drive project governance, phase-gate reviews and team decision making
• Develop and maintain program risk management plans, risk logs and escalation processes
• Coordinate preparation of FDA submission packages with the Regulatory team
• Coordinate launch planning across Marketing, Commercial, Clinical and Customer Service
• Coach and mentor project team members and functional managers

Required qualifications

• Bachelor's degree in Engineering, Science, Business or related field
• 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 and quality systems

Nice to have

• Experience with implantable medical devices
• Experience with neurostimulation products
• Experience with electromechanical medical systems
• Experience with Agile and Stage-Gate development models
• Experience in 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 meeting minutes, dashboarding, reporting and 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

Benefits

• Multiple health insurance plan options
• Employer contributions to Health Savings Account
• Dental, vision, life and disability benefits
• 401k plan with employer match
• Identity protection
• Flexible time off
• Tuition reimbursement
• Employee assistance program
• Equity awards and Employee Stock Purchase Program

Before you apply

• Inspire Medical Systems participates in E-Verify

About the company

Inspire Medical Systems makes an FDA-approved medical device that reduces obstructive sleep apnea severity for people who cannot tolerate or benefit consistently from CPAP. The company puts patient outcomes, integrity and respect first.